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The latest on how medical technology is changing lives for the better

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TriVascular wins FDA nod for customized aneurysm-sealing tech
The FDA has granted TriVascular Technologies approval to market its CustomSeal Technology, designed to deliver the Ovation ...Learn More
Funding round brings in $32.5M for diabetes tech developer
A round of Series C financing headed by Norwest Venture Partners has pulled in $32.5 million for Telcare. ...Learn More
Maker of flexible endoscope obtains $20M in financing
Massachusetts-based Medrobotics has raised $20 million in its latest financing round. ...Learn More
Ill. molecular Dx firm launches public stock sale
Nanosphere has initiated a public shares offering, with plans to use the proceeds as working capital and to support general ...Learn More
Infectious-disease-product sales boost Q3 revenue for Quidel
California-based Quidel posted $40.9 million in revenues during the third quarter, up from $33.5 million during the same ...Learn More
Clinical Genomics gains license for bowel cancer Dx test
The Commonwealth Scientific and Industrial Research Organisation in Australia has agreed to license its ColoVantage Plasma ...Learn More
Mammography market in the Americas could hit $1.1B in 6 years
A GBI Research report forecasts that the market for mammography devices in the Americas will reach $1.1 billion by 2020. ...Learn More
Hansen's device used in first robotic fibroid embolization in U.S.
A doctor at the Sierra Medical Center in Texas has performed the first robotic fibroid embolization in the U.S. ...Learn More
Medtronic's PTC-based interbody fusion devices make global debut
Medtronic said its pure titanium coating-based interbody fusion systems, designed to help treat patients with spinal ...Learn More
BioMerieux pursues approval of FilmArray test for Ebola screening
BioMerieux will evaluate its FilmArray system to determine whether it can be used to detect the Ebola virus in preparation ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Minds are like parachutes; they work best when open.
Thomas Dewar, Scottish ...Learn More
Medtech delivers value well in excess of its cost, AdvaMed CEO says
Studies citing medical technology as a major reason for escalating health costs are misguided, writes AdvaMed President and ...Learn More
ZipLine Medical receives $5.7M from Chinese investor
California-based ZipLine Medical, maker of the Zip system designed to close surgical incisions, has obtained $5.7 million ...Learn More
Orthopedics and prosthetics market poised for growth
A ReportsNReports study forecasts that the orthopedic and prosthetic device market will see a compound annual growth rate of ...Learn More
Brainsway strikes marketing deal, wins reimbursement for Deep TMS device
A French company has agreed to sell Brainsway's Deep Transcranial Magnetic Stimulation system, an FDA-approved device used ...Learn More
Report: Asian arthroscopic device market could exceed $700M by 2018
A report from MicroMarket Monitor predicts that by 2018, the Asian market for arthroscopic systems could surpass $700 ...Learn More
Canada OKs Otoharmonics' tinnitus device
Otoharmonics has received the go-ahead in Canada to market its Levo System as a Class 2 medical device. ...Learn More
Trial begins for Ablative Solutions' infusion ablation catheter
A clinical trial launched by Ablative Solutions in Poland aims to investigate the use of its infusion ablation catheter as a ...Learn More
Sensor has potential to detect viruses at very low levels
A new sensor can detect small traces of target molecules, which could lead to earlier diagnoses of illnesses such as Ebola, ...Learn More
DexCom gains FDA approval for wireless glucose monitoring device
The FDA gave pre-market approval for the DexCom Share device, part of its remote glucose monitoring system that transmits ...Learn More
AnthroTronix's cognitive health testing app gets FDA OK
AnthroTronix has received FDA clearance to market the Defense Automated Neurobehavioral Assessment, or DANA, application, ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
Nobody can go back and start a new beginning, but anyone can start today and make a new ending.
Maria Robinson, American ...Learn More
Device sector saw rise in VC deals in Q3, report says
A MoneyTree report from the National Venture Capital Association and PricewaterhouseCoopers found that the medical device ...Learn More
Colo. sinusitis device startup obtains $8.3M in financing
A round of financing has pulled in $8.3 million for Sinopsys Surgical. ...Learn More
Abbott agrees to market Carl Zeiss' cataract surgery devices
Abbott will add Carl Zeiss Meditec's cataract surgery devices to its eye surgery offerings under a deal reached between the ...Learn More
Calif. molecular Dx company posts revenue growth in Q3
California-based Cepheid, which specializes in molecular diagnostics, posted $115.2 million in revenues during the third ...Learn More
EU approves MRI-safe pacemaker from Boston Scientific
European regulators have granted Boston Scientific CE mark approval to market its Accolade pacemaker. ...Learn More
Trial underway for Medtronic's predictive low glucose management tech
Medtronic has begun patient enrollment in a clinical study of its Predictive Low Glucose Management system, which combines a ...Learn More
Foundation Medicine scores reimbursement win for cancer genomic tests
Priority Health has become the first U.S. ...Learn More
New PET/CT system from Mediso designed for research use
Mediso Medical Imaging Systems has introduced the MultiScan LFER 150 PET/CT device, created for use in preclinical and ...Learn More
NHD taps Rayence to supply flat-panel digital detectors
Rayence has struck a deal to provide the National Healthcare Distributors' network of sales and service providers with its ...Learn More
Federal judge rules in favor of Covidien in injunction decision
A federal judge ruled in favor of Covidien last week by imposing a preliminary injunction that prohibits Ethicon ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
We have committed the Golden Rule to memory; let us now commit it to life.
Edwin Markham, American ...Learn More
Report: Medtech, biotech and pharma see strong M&A activity
A recent report from Mergermarket found that the medtech, biotech and pharma industries had 869 merger and acquisition deals ...Learn More
Calif. eye surgery device firm receives $51M funding boost
A round of financing headed by Frontline BioVentures and OrbiMed has pulled in $51 million for MID Labs, which develops ...Learn More
Stock sale brings in $5.3M for Epigenomics
Epigenomics, which has developed the Epi proColon test used to diagnose colorectal cancer, has obtained $5.3 million through ...Learn More
Industry veteran joins Spine Wave's marketing management team
Laine Mashburn has been tapped to serve as executive vice president of global marketing and business development at Spine ...Learn More
EU approves Thermo Fisher's Ion PGM Dx tool
European regulators have granted Thermo Fisher Scientific the CE-IVD mark to market its Ion PGM Dx System. ...Learn More
Genetic test identifies patients at risk of atrial fibrillation and stroke
Scientists have developed a test that screens for 12 genetic variants to determine risk of ischemic stroke and atrial ...Learn More
Siemens' advanced cardiovascular ultrasound scanner gets FDA OK
Siemens Healthcare has received FDA clearance for the Acuson SC2000 Prime, the latest version of its ultrasound scanner used ...Learn More
Wireless imaging device from Konica lands FDA clearance
The AeroDR XE wireless digital radiography device, developed by Konica Minolta Medical Imaging, has obtained clearance from ...Learn More
ITraumaCare's bleeding-control device gets expanded approval from FDA
The FDA has granted iTraumaCare expanded approval for its iTClamp Hemorrhage Control System for use in halting severe ...Learn More
FDA clears cervical fusion device from Precision Spine
The FDA has cleared Precision Spine to market its Vault-C Anterior Cervical Interbody Fusion Device, which the company said ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
People are like stained-glass windows. They sparkle and shine when the sun is out, but when the darkness sets in, their true beauty is revealed only if there is a light from within.
Elisabeth Kubler-Ross, American ...Learn More
Swedish maker of thumb-based ECG device eyes $1.7M in IPO
Swedish firm Zenicor Medical Systems has filed for an initial public offering in hopes of obtaining $1.7 million. ...Learn More
N.H. breast-imaging device startup obtains $6.5M
A regulatory filing shows that Gamma Medica has obtained $6.5 million in its latest funding round. ...Learn More
Tenn. genetic testing firm gains $2.23M in additional financing
The second tranche of a Series B funding round has pulled in $2.23 million for NextGxDx, according to a regulatory filing. ...Learn More
Delphinus Medical appoints new engineering VP
Chris Sanders has been tapped to serve as vice president of engineering at Delphinus Medical Technologies. ...Learn More
Forum seeks comments on problematic-device reporting proposal
A document issued by the International Medical Device Regulators Forum outlines the group's proposal to modify its process ...Learn More
Skyline teams up with Sao Paulo researchers to evaluate leukemia test
SkylineDx will conduct a study with researchers at the Ribeirao Preto Medical School at the University of Sao Paulo to ...Learn More
Medical device tax: A hat trick of futility
In just 21 months, the 2.3% levy has achieved a unique hat trick of futility. ...Learn More
InVivo reports first implantation of spinal scaffold
A patient at a hospital in Arizona has become the first to be implanted with InVivo Therapeutics' Neuro-Spinal Scaffold as ...Learn More
CMS to cover BioTheranostics' breast cancer index test
The CMS has agreed to provide Medicare reimbursement coverage for BioTheranostics' Breast Cancer Index assay. ...Learn More
Aethlon's biofiltration device used to treat Ebola patient
Aethlon Medical has announced that its Hemopurifier blood filtration device is being used at Frankfurt University Hospital ...Learn More
FDA clears HPIV test from Quidel
The FDA has given Quidel 510(k) clearance to market its Lyra Parainfluenza Assay. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Every great dream begins with a dreamer.
Harriet Tubman, American ...Learn More
Medtronic wins FDA nod for MRI-safe pacemaker lead
The FDA has granted Medtronic approval for its CapSureFix Novus MRI SureScan 5076 pacemaker lead. ...Learn More
Becton enters next-generation sequencing market with GenCell buy
Becton Dickinson has agreed to pay an undisclosed sum to purchase GenCell Biosystems, an Irish firm specializing in ...Learn More
Maker of total artificial heart advances $15M funding round
A regulatory filing disclosed that Syncardia has obtained $6.4 million in a Series F financing round aiming for $15 million. ...Learn More
Mazor Robotics appoints new CEO
Christopher Prentice has been promoted from senior vice president of America and global marketing to CEO of Mazor Robotics. ...Learn More
EU nod sought by Medtronic for proposed $43B merger with Covidien
The European Commission said Medtronic has sought the approval of antitrust regulators in Europe for its pending acquisition ...Learn More
Device, drug regulatory agencies in Bulgaria, Sweden get new leaders
The Bulgarian Drug Agency has appointed Assena Stoimenova as its new executive director, while the Medical Products Agency ...Learn More
Collaboration aims to develop test for early TB diagnosis
Advanced Biological Laboratories has struck a development deal with two universities in Hong Kong for undisclosed terms. ...Learn More
VisionCare's eye device obtains wider FDA approval
VisionCare Ophthalmic Technologies has received expanded FDA approval for its miniature telescope implant to be used in ...Learn More
Final FDA guidance distinguishes device recalls from market withdrawals
Guidance outlining requirements for differentiating medical device recalls from market withdrawals has been finalized by the ...Learn More
Tool for CT-based bone mineral density measurement gets FDA OK
The FDA has cleared MindwaysCT to market its computed tomography calibration system for use in measuring bone mineral ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Sometimes you have to step outside of the person you've been, and remember the person you were meant to be, the person you wanted to be, the person you are.
H.G. Wells, British ...Learn More
Steris to acquire British sterilization firm in $1.9B deal
Steris has agreed to pay roughly $1.9 billion in cash and company stock to acquire Synergy Health, a British provider of ...Learn More
Funding round brings in $120M for Invitae
A Series F financing round has pulled in $120 million for Invitae, maker of a gene-based test that can be used to detect ...Learn More
Advanced Biologics' bone allograft sold to Bioventus
Advanced Biologics has agreed to sell its OsteoAMP bone allograft product line to Bioventus, which will market the product ...Learn More
Ohio stroke device startup eyes $3.1M in additional financing
A regulatory filing shows that Ischemia Care has obtained $1.9 million in equity financing and hopes to raise $3.1 million ...Learn More
Ophthalmology device market poised for growth, report says
A Markets & Markets report predicts that the market for ophthalmology devices used for diagnostics, monitoring, vision care ...Learn More
Device could aid in early detection of Ebola virus infection
A device developed by Noninvasive Medical Technologies could allow clinicians to pinpoint Ebola patients before symptoms ...Learn More
Medical device coating resists blood clots and bacterial growth
Harvard University researchers have developed a coating for medical devices that blocks the formation of blood clots and ...Learn More
FDA OKs adenovirus molecular Dx test from Quidel
The FDA has given Quidel 510(k) clearance to sell its real-time polymerase chain reaction-based test called the Lyra ...Learn More
Portable patient monitor from Covidien wins FDA nod
The Nellcor Portable SpO2 Patient Monitoring System by Covidien has been cleared by the FDA. ...Learn More
FDA widens clearance for Nanosphere's enteric pathogens test
The FDA has granted Nanosphere expanded 510(k) clearance for its Verigene Enteric Pathogens Nucleic Acid Test to be used in ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
The free soul is rare, but you know it when you see it -- basically because you feel good, very good, when you are near or with them.
Charles Bukowski, German-born American ...Learn More
Bard gains FDA approval for drug-coated balloon catheter
The FDA has given C.R. Bard the green light to market its drug-coated balloon catheter. ...Learn More
Medtronic unveils restructuring plans after Covidien acquisition
Medtronic said Covidien will operate as a separate unit after it acquires the company in a $43 billion transaction. ...Learn More
Great Basin Scientific to sell 1.15 million shares in IPO
Great Basin Scientific said in a regulatory filing that it will sell 1.15 million company shares valued at $7 apiece in an ...Learn More
Funding round brings in $11.6M for esophageal device maker
C2 Therapeutics, a California-based startup that has developed the Coldplay Focal Cryoballoon Ablation System, has obtained ...Learn More
EU approves RPS Diagnostics' respiratory infection test
RPS Diagnostics has obtained the CE mark for its in-office diagnostic test FebriDx. ...Learn More
Biotronik's hybrid drug-eluting stent hits French market
The Orsiro hybrid drug-eluting stent is available commercially in France, according to Biotronik, which developed the ...Learn More
Ind. patient becomes first in U.S. to receive Sorin's heart valve
Sorin's Solo Smart system has been implanted for the first time in the U.S. in a patient in Indiana. ...Learn More
Microfluidics may be better way to identify Ebola
Microfluidics applied to bodily fluids may be the key to quick and early detection of the Ebola virus, says Juan Pablo ...Learn More
Upgraded ultrasound scanner released by Siemens
Version 3.5 of the Acuson Freestyle ultrasound scanner is available commercially, according to Siemens Healthcare, which ...Learn More
FDA OKs Spineart's cervical secured cage technology
The FDA has given Spineart the go-ahead for its cervical secured cage technology known as the SCARLET AC-T. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
If you want to be successful, you must respect one rule: Never lie to yourself.
Paulo Coelho, Brazilian ...Learn More
Mass. knee cartilage device firm targets $65M in IPO
Massachusetts-based Histogenics plans to launch an initial public offering in a quest to obtain as much as $65 million. ...Learn More
AngioDynamics posts profit growth in FY 2015 first quarter
AngioDynamics generated $629,000 in net income during the first quarter of fiscal year 2015, which represents an increase ...Learn More
EOS hits milestone for imaging technology
Royal Children's Hospital in Melbourne, Australia, has installed a unit of EOS imaging's technology, designed for 2D and 3D ...Learn More
Global sales of connected health care devices poised for growth
A Juniper Research report projects that global sales of connected health care devices such as sleep apnea monitors and ...Learn More
EU approves TB molecular Dx test from Abbott
European regulators have granted Abbott the CE mark for its assay that runs on the company's m2000 molecular testing ...Learn More
Ocular Therapeutix proceeds with 2 eye-duct plug studies
Ocular Therapeutix is set to launch two late-stage clinical trials of its OTX-DP technology, an eye-duct plug that ...Learn More
SomaLogic teams up with Colo. hospital for childhood disease biomarker study
SomaLogic is working with Children's Hospital Colorado to advance research on protein biomarkers for managing and diagnosing ...Learn More
Tumor segmentation tool from Varian OK'd by FDA
Varian Medical Systems has received FDA clearance for software that supports lung tumor segmentation in 3D. ...Learn More
Knee replacement device from OrthAlign debuts in U.K.
The KneeAlign system, a single-use device that offers femoral and tibial navigation during knee replacement procedures, was ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
To be yourself in a world that is constantly trying to make you something else is the greatest accomplishment.
Ralph Waldo Emerson, American ...Learn More
IPO could bring in $60M for AutoGenomics
California-based AutoGenomics is looking to obtain $60 million in an initial public offering. ...Learn More
Funding round pulls in $45.3M for TELA Bio
A regulatory filing shows that TELA Bio has obtained $45.3 million in its latest financing round. ...Learn More
U.S. patent issued to aap Implantate's LOQTEQ system
The U.S. ...Learn More
CEO of AxioMed Spine joins Misonix's board
Patrick McBrayer has been tapped to serve on the board of directors at Misonix. ...Learn More
Report: 3D printing poised to see growth in medical applications market
A Transparency Market Research report predicts that by 2019, 3D printing in the global medical applications market could be ...Learn More
Is medtech held to a double standard on innovation? A conversation with B. Braun's Caroll Neubauer
MassDevice.com catches up with B. ...Learn More
Advanced Cell Diagnostics receives $1.4M to validate lymphoma assay
The National Cancer Institute has awarded Advanced Cell Diagnostics a $1.4 million small business innovation research grant ...Learn More
Medtronic's sacral neurostimulation assessment tool gets FDA OK
The FDA has granted Medtronic approval to market its Verify Evaluation System for use in assessing which patients with ...Learn More
Ubl: Industry fears over 2.3% medical device tax bear out
AdvaMed President and CEO Stephen Ubl said concerns over the 2.3% medical device tax are proving to be true almost two years ...Learn More
Boston Scientific gets mixed FDA panel review for heart device
An FDA panel has agreed that Boston Scientific's Watchman system is potentially safe, but it was split on whether the ...Learn More
Clip failure concerns lead SAM Medical to recall Junctional Tourniquet
SAM Medical Products has issued a voluntary recall involving its SAM Junctional Tourniquet over concerns about possible clip ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
It is not the voice that commands the story; it is the ear.
Italo Calvino, Italian journalist and ...Learn More
Revenue, IPO, funding and M&A growth seen in medtech sector in 2013
An Ernst & Young report found that public medtech companies in Europe and the U.S. ...Learn More
$1.39M fund raised for Healthbox's accelerator program in Utah
A regulatory filing shows Healthbox has secured a fund worth $1.39 million, which will go toward its health care accelerator ...Learn More
Mayor calls on medical-device-makers to set up shop in Chicago
During a breakfast meeting Tuesday at the AdvaMed conference, Chicago Mayor Rahm Emanuel said efforts are underway to expand ...Learn More
Sequenom acquires Isis' prenatal testing IP in $14.6M deal
Sequenom has agreed to pay Isis Innovation almost $14.6 million to acquire global intellectual property covering the ...Learn More
CEO of Allergan resigns seat on Edwards' board
David Pyott has stepped down as a board director at Edwards Lifesciences. ...Learn More
Report pegs global patient monitoring market at $29.7B
The global market for patient monitoring systems is currently valued at $29.7 billion, a 7% increase from 2013, according to ...Learn More
Trial will test use of Biosense's uChek app in eclampsia detection
Merck for Mothers is partnering with Biosense Technologies to conduct a pilot study evaluating the latter's uChek system, a ...Learn More
Breast specimen tomo system from Kubtec wins FDA nod
The FDA has cleared Kubtec to market its Mozart with TomoSpec system, designed for breast specimen radiography and ...Learn More
New assay uses synthetic biomarkers to detect blood clots
Scientists have developed a new nanoparticle-based assay that detects blood clots, and it has been tested successfully in ...Learn More
Hamburg: FDA developing strategies to bring devices to market faster
The FDA is taking steps to simplify its medical-device-approval program "to make sure really promising products can move ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
We adore chaos because we love to produce order.
M.C. Escher, Dutch graphic ...Learn More
AdvaMed: New payment models could stymie innovation
Important medical technology innovations could be blocked by the pay-for-performance and risk-based models for reimbursement ...Learn More
IPO could pull in more than $100M for Nevro
California-based Nevro said in a regulatory filing that it plans to launch an initial public offering in hopes of obtaining ...Learn More
Report: Medtech market sales could reach $514B by 2020
An EvaluateMedTech report projects that the medical device market could see $514 billion in sales over the next six years, ...Learn More
Stryker's purchase of Small Bone Innovations finalized
Stryker has wrapped up its purchase of Small Bone Innovations, acquiring the company's European and Asian operations. ...Learn More
Immunodiagnostic Systems moves N. American base to Md.
Immunodiagnostic Systems has transferred its North American base from Scottsdale, Ariz., to a 10,000-square-foot facility in ...Learn More
Asian orthobiologics market could hit $700M in 4 years, report says
A report from MicroMarketMonitor predicts that by 2018, the Asian orthobiologics market could be worth about $700 million, ...Learn More
Irish embolization device firm receives $3.8M funding boost
A group of investors has pumped about $3.8 million into Embo Medical, which is working on a device that can be used to halt ...Learn More
Engineers develop 3D program to track living cells
Drexel University scientists have created a three-dimensional software that can identify live cells and monitor their ...Learn More
Trial underway for Claret's cerebral protection device
A patient at the New York-Presbyterian Hospital/Columbia University Medical Center has become the first to be treated with ...Learn More
Integra resolves manufacturing issues at Puerto Rican facility
Integra LifeSciences has resolved all of the issues raised in an FDA warning letter it received in February 2013 over ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Freedom means the opportunity to be what we never thought we would be.
Daniel Boorstin, American ...Learn More
CareFusion to be acquired by Becton, Dickinson in $12.2B deal
Becton, Dickinson & Co. ...Learn More
Medtronic to use external financing to pursue Covidien deal
Medtronic has announced that it will not fund its acquisition of Covidien using foreign cash as it originally planned, but ...Learn More
Immucor acquires Sentilus
Immucor has announced that it has purchased Sentilus, the developer of Femtoarrays, an antibody microarray-based technology. ...Learn More
Ahead of planned IPO, Second Sight Medical obtains $3M
Second Sight Medical, maker of the FDA-approved Argus II eye implant designed to treat retinitis pigmentosa, has secured a ...Learn More
First Warning rebrands to reflect core-business focus
To better depict its core competencies and business focus, First Warning Systems has been rebranded as Cyrcadia Health. ...Learn More
Australian regulators OK Koning's breast CT technology
Koning has secured the go-ahead to market its breast CT scanning device in Australia. ...Learn More
Firm gains funds to conduct studies of Alzheimer's Dx test
A round of Series D financing has pulled in more than $15 million for Cognoptix. ...Learn More
Portable machine would diagnose Ebola
A silicon chip is at the heart of a portable device designed to quickly diagnose the Ebola virus and similar hemorrhagic ...Learn More
In-home male fertility screening test hits U.S. market
SpermCheck said its FDA-approved assay designed for in-home male fertility screening is available commercially. ...Learn More
FDA whistleblowers lawsuit dismissed by federal judge
A whistleblower lawsuit filed against the FDA in which it was accused of spying on the private e-mail accounts of its ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Every adversity, every failure, every heartache carries with it the seed of an equal or greater benefit.
Napoleon Hill, American ...Learn More
Zimmer to expand biologics portfolio with Etex acquisition
Zimmer has struck a deal to acquire Etex, maker of the EquivaBone bone void filler already cleared by the FDA for trauma ...Learn More
Minn. male-incontinence-device firm lands $5M in fresh capital
GT Urological, maker of a prosthetic implant used to treat male stress-urinary incontinence, has obtained $5 million in its ...Learn More
Covidien, Medtronic gear up for peripheral vascular biz integration
As part of their pending $43 billion merger deal, Covidien and Medtronic have named representatives to a team that will be ...Learn More
VolitionRx enters partnership on anaplastic prostate cancer testing
The University of Texas MD Anderson Cancer Center is partnering with VolitionRx to assess the latter's NuQ test in ...Learn More
EU approves Direct Flow's enhanced heart valve delivery system
European regulators have granted Direct Flow Medical CE mark approval to market an updated delivery system used with its ...Learn More
InfraScan wins contract to advance brain scanner development
InfraScan has received a $3.7 million four-year military contract to support the development of its new brain hematoma ...Learn More
Study shows positive results for BONESUPPORT's bone healing system
A clinical study of chronic osteomyelitis patients found that BONESUPPORT's CERAMENT|G system led to complete wound healing ...Learn More
New lymphocyte test can detect cancer and risk of malignancies
Scientists say a newly developed lymphocyte genome sensitivity test could allow earlier cancer detection and eliminate the ...Learn More
Final guidance on medical device cybersecurity issued by FDA
Final guidelines released by the FDA would require medtech companies to include documentation in their premarket submissions ...Learn More
Esaote's MyLab Gamma ultrasound scanner OK'd by FDA
Esaote North America has been cleared by the FDA to market its MyLab Gamma ultrasound scanner. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. – 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
Taking a chance and stepping beyond the safety of the world we've always known is the only way to grow.
Wil Wheaton, American ...Learn More
EndoStim plans to go public to raise $35M
EndoStim plans to launch an initial public offering in hopes of obtaining about $35 million. ...Learn More
NuVasive moves to expand global presence
NuVasive hopes to increase its global presence with the launch of its European Center of Excellence in Amsterdam. ...Learn More
Renaissance RX's facility expansion in La. could add 425 jobs
Renaissance RX, which specializes in pharmacogenetic tests used to determine patients' responses to certain drugs, is moving ...Learn More
Amedica appoints board chairman as CEO
Dr. B. Sonny Bal has been tapped to serve as president and CEO of Amedica. ...Learn More
LoneStar's hydrogel heart implant wins approval in Europe
The Algisyl-LVR hydrogel implant, developed by LoneStar Heart, has obtained CE mark approval in Europe. ...Learn More
SI-BONE to set up new unit's headquarters in Germany
SI-BONE, which develops minimally invasive devices for sacroiliac joint fusion procedures, has established a GmbH in a move ...Learn More
Checking on Orange County's medtech climate with OCTANe's Matthew Jenusaitis
Orange County, Calif.'s most-networked man, OCTANe's Matthew Jenusaitis, talks to MassDevice.com about medtech in the OC and ...Learn More
2-year trial of Bionic Vision's eye implant completed
Bionic Vision Australia has wrapped up a two-year study evaluating its 24-channel suprachoroidal electrode implant in three ...Learn More
MindwaysCT's bone density software lands FDA clearance
The FDA has cleared MindwaysCT to sell an advanced version of its quantitative CT scanning software that can transform CT ...Learn More
HHS awards $20.8M for influenza-test development
HHS has awarded Alere a $12.9 million contract to continue the development of its iNAT molecular test, which the company ...Learn More
FDA offers $19M in grants to advance rare disease research
The FDA has committed more than $19 million to advance the development of drugs, medical devices and biologics that address ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
You're going to come across people in your life who will say all the right words at all the right times. But in the end, it's always their actions you should judge them by.
Nicholas Sparks, American ...Learn More
Docs net $3.5B in industry payments, ACA database shows
Doctors were paid at least $3.5 billion by makers of drugs and medical devices from August to December 2013, according to ...Learn More
For more:
Read the statement from Christopher White, AdvaMed's senior executive vice president and general counsel, about the launch ...Learn More
Consort Medical to boost drug-device footprint with Aesica buy
Consort Medical, which specializes in disposable drug delivery devices, has agreed to pay $373 million to buy Aesica ...Learn More
Calif. orthopedic device firm receives $8M investment
Breakwater Investment has made an $8 million investment in Consensus Orthopedics. ...Learn More
Financing round pulls in $26.2M for Acutus Medical
California-based Acutus Medical has obtained $26.2 million in its latest funding round. ...Learn More
Impact Instrumentation wins $35M contract from Pentagon
The Defense Department has awarded Impact Instrumentation a contract to supply the department's military units and federal ...Learn More
EU grants CE mark to EDP's colorectal cancer test
European regulators have given EDP Biotech the CE mark for its ColoMarker test, which is used to detect colorectal cancer ...Learn More
GlaxoSmithKline launches $5M bioelectronics innovation fund
GlaxoSmithKline has set up a $5 million fund to support academics and startup companies developing mini-implantable ...Learn More
Advanced spinal-surgery-planning tool from Nemaris gets FDA OK
The FDA has cleared Nemaris to market Surgimap 2.0, a next-generation version of its software designed for preoperative ...Learn More
FDA warning letters dipped for first time in 5 years, report says
A report from the FDA's device center shows that the number of warning letters issued by the agency to medical-device ...Learn More
2 draft guidelines on lab-developed tests issued by FDA
The FDA has released a pair of draft guidelines governing laboratory-developed tests, which will be open for public comment ...Learn More
For more:
Read the statement from AdvaMedDx Executive Director Andrew Fish about the FDA's LDT draft ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Life appears to me too short to be spent in nursing animosity, or registering wrongs.
Charlotte Bronte, British ...Learn More
Advanced robotic "wrist" from Intuitive Surgical gets FDA OK
The FDA has cleared Intuitive Surgical to market its advanced robotic "wrist" known as the Single-Site Wristed Needle Driver ...Learn More
Report: U.S. market for joint, large-bone devices poised for growth
An iData research report forecasts that by 2020, the market for joint and large-bone devices in the U.S. ...Learn More
Company developing medtech sharing tool collects $3.1M in funding round
A debt funding round aiming for $5.8 million has brought in $3.1 million for Cohealo. ...Learn More
AltheaDx gains OK to offer pharmacogenetic tests in N.Y.
The New York State Department of Health has authorized AltheaDx to offer its IDgenetix line of pharmacogenetic tests in the ...Learn More
Brain aneurysm device from Medina Medical clears EU hurdle
The Embolization Framing Coil, developed by Medina Medical, has obtained CE mark approval in Europe. ...Learn More
First in-human use of tricuspid valve repair device reported in Germany
A patient in Germany has become the first to receive Mitralign's device used to treat tricuspid valve regurgitation. ...Learn More
Dallen's surgical staple used for first time clinically
Dallen Medical said its FDA-cleared Compressyn Staple has been used to treat an arthritic foot via calcaneal cuboid fusion ...Learn More
Iluvien DME implant gains FDA OK
The FDA has approved the Iluvien eye implant from pSivida and Alimera Sciences. ...Learn More
FDA's rescission of ReGen's knee implant reversed by appeals court
The FDA's move to revoke its 510(k) clearance for the MenaFlex knee implant developed by ReGen Biologics has been reversed ...Learn More
3 additional targets for Luminex's GI test panel OK'd by FDA
The FDA has cleared Luminex to market its xTAG Gastrointestinal Pathogen Panel for use in detecting three new pathogens: ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
The awareness of our own strength makes us modest.
Paul Cezanne, French ...Learn More
Gore gains wider FDA approval for Viabahn system
The FDA has granted W.L. Gore & Associates expanded premarket approval for the company's Viabahn endoprosthesis. ...Learn More
Medtronic pledges $6M for rheumatic heart disease program
Medtronic has committed to donate $6 million as part of an effort by the United Nations to improve children and women's ...Learn More
Aethlon unit to help develop chronic traumatic encephalopathy test
The Boston University CTE Center will work with Exosome Sciences, an Aethlon Medical unit, to create a blood-based assay for ...Learn More
Thermo partners with 2 drugmakers on cancer companion Dx test
Thermo Fisher Scientific has agreed to work with Pfizer and GlaxoSmithKline to create a universal oncology assay that can ...Learn More
Ukraine's new medtech conformity-assessment system to take effect in 2015
Recent correspondence between Ukraine's Ministry of Health and Cratia, a health care products regulatory consulting firm ...Learn More
EU approves 2 catheters from ReFlow Medical
ReFlow Medical said it has obtained CE mark approval in Europe for a pair of devices that work in tandem to cross lesions in ...Learn More
2 health facilities to split $1M for cancer genomics efforts
A donation worth $1 million will be equally shared between University Hospitals and Cleveland Clinic to finance their cancer ...Learn More
CVRx gets CE mark approval for heart-failure treatment device
CVRx received CE mark approval for its Barostim neo implantable device that is used for patients with heart failure. ...Learn More
Needle-guidance tech from Clear Guide lands FDA clearance
Clear Guide Medical received FDA clearance to market a navigation product that works with most ultrasound devices, tools and ...Learn More
Metrics-based FDA inspection guidelines could come by end of 2014
The FDA plans to release 13 product-specific guidelines by the close of this year meant to inform medical-device companies ...Learn More
FDA panel to consider new indication for Alcon's intraocular lens
An FDA panel of advisers will convene Nov. ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
A 'No' uttered from the deepest conviction is better than a 'Yes' merely uttered to please, or worse, to avoid trouble.
Mahatma Gandhi, Indian civil rights leader and political ...Learn More
LabCorp to pay $85M for LipoScience
Laboratory Corp. ...Learn More
Stock sale brings in $46M for Vital Therapies
California-based Vital Therapies has obtained $46 million in a public shares offering. ...Learn More
Minn. spinal-device-maker receives $10M funding boost
A funding round has pulled in $10 million for Zyga Technology, which develops devices for treating spinal disorders in the ...Learn More
EU approves blood clot analyzer from Microvisk
European regulators have granted Microvisk the CE mark for its CoagMax PT/INR system. ...Learn More
Teleflex puts money into Czech facility expansion
Teleflex Medical, which develops central venous catheters and other surgical devices, said it will expand its manufacturing ...Learn More
Pentagon awards supply contracts to Zoll, Philips
The Defense Department has awarded Zoll Medical and Philips separate contracts worth as much as $39.8 million and $27.4 ...Learn More
Nova StatStrip device gets expanded FDA OK for use in critical care
Nova Biomedical received expanded clearance for its Nova StatStrip system to be used in critical care units within ...Learn More
Life Spine's expandable lateral interbody device wins FDA nod
The FDA has cleared Life Spine to market its LONG BOW system, an expandable interbody device designed to allow surgeons ...Learn More
Customized device exemption rules finalized by FDA
The FDA has finalized its guidelines governing the exemption of certain personalized medical devices from premarket approval ...Learn More
FDA seeks to align U.S. and global fluoroscopy standards
Draft guidance aimed at aligning the U.S. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. – 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
One way to get the most out of life is to look upon it as an adventure.
William Feather, American ...Learn More
Quantel wins EU approval for eye laser technology
European regulators have given Quantel Medical the CE mark for its Vitra PDT system, which the company aims to launch ...Learn More
Calif. glaucoma-device-maker obtains $25M in fresh capital
A funding round has brought in $25 million for California-based Ivantis. ...Learn More
Company developing prosthetic implant advances $4.2M funding round
A regulatory filing shows that Palmaz Scientific has obtained $1.3 million in a funding round aiming for $4.2 million. ...Learn More
3 firms partner for colon cancer Dx test development
Scienion and BioVendor have agreed to work with the Austrian Institute of Technology to create an in vitro diagnostic test ...Learn More
Genetic tests from Sophia receive approval in Europe
European regulators have granted Sophia Genetics the CE mark for its genetic tests that work with the company's ...Learn More
Viatom Technology gets CE mark for Checkme health monitor
China-based Viatom Technology has earned the CE mark in Europe for its Checkme system, which offers one-lead ...Learn More
What's behind the slump in early-stage medtech investment?
Blame the medical device tax and the U.S. ...Learn More
NCI awards $1.5M for leukemia companion Dx test development
Eutropics will further develop its Praedicare Dx system using a $1.5 million grant from the National Cancer Institute. ...Learn More
Research groups get $17M boost to develop 3D tissue chips
Eleven research organizations have received $17 million from the NIH to create 3D chips that mimic human tissue for use in ...Learn More
Device used during IV drug administration gains FDA OK
The FDA has cleared Anesthesia Safety Products to market its AirPurge System, designed for the automatic removal of air ...Learn More
FDA OKs interbody fusion device from Nanovis Spine
The FortiCore system, developed by Nanovis Spine, has obtained 510(k) clearance from the FDA. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group or follow them on Twitter!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
How far you go in life depends on your being tender with the young, compassionate with the aged, sympathetic with the striving and tolerant of the weak and strong. Because someday in your life you will have been all of these.
George Washington Carver, American scientist and ...Learn More
EndoCross wins EU approval for device to cross coronary lesions
Regulators in Europe have granted the CE mark to EndoCross' ENABLER-C Coronary Catheter System, designed to enable crossing ...Learn More
Philips unveils restructuring plans
Royal Philips has announced plans to divide into two businesses: one that concentrates on lighting technologies and another ...Learn More
Calif. startup behind menstrual-bleeding device gets $25M boost
Minerva Surgical, which is working on a device that it says can help reduce excessive menstrual bleeding in just four ...Learn More
Grossman retakes the reins at Thoratec
Thoratec has appointed Keith Grossman to again serve as its CEO, replacing Gary Burbach, who resigned on Monday. ...Learn More
Genetic Technologies agrees to $1.8M sale of Australian Genetics unit
Genetic Technologies, which specializes in molecular diagnostic tests, has unveiled plans to divest itself of its Australian ...Learn More
Mobidiag gains CE mark for bacterial gastroenteritis test
Mobidiag has launched its Amplidiag Bacterial GE test in Europe, which comes on the heels of CE mark approval for the ...Learn More
Firm obtains funds to support circulating tumor DNA test development
A financing round headed by Imperial Innovations has brought in $6.6 million for Inivata, a spinoff of Cancer Research UK. ...Learn More
T2 Biosystems' sepsis tests receive clearance from FDA
The FDA has authorized T2 Biosystems to market its T2Dx Instrument and T2Candida Panel sepsis screening tools. ...Learn More
FDA seeks comments on proposed standardized device labeling study
A proposal to conduct a study evaluating standardized labeling for medical devices has been issued by the FDA. ...Learn More
Feds plan workshop on cybersecurity of medical devices
The FDA will host a workshop on Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
True happiness is ... to enjoy the present, without anxious dependence upon the future.
Seneca, Roman philosopher and ...Learn More
Exagen plans to go public to raise up to $69M
Exagen Diagnostics, whose flagship product is the Avise SLE+CT assay used to detect autoimmune rheumatic diseases, is ...Learn More
Report forecasts strong growth for spinal-surgery-device market
A MarketsandMarkets report predicts that the worldwide market for spinal-surgery systems could be worth $14.8 billion in ...Learn More
Cologuard test to be covered by Wis. health plan
Group Health Cooperative has agreed to cover Exact Sciences' Cologuard test as part of its patients' laboratory benefits, ...Learn More
Medtronic's heart-device envelope gains approval in Europe
Medtronic has earned the CE mark in Europe for its Tyrx system, an antibacterial heart-device envelope that releases the ...Learn More
EU grants MRI-safe labeling for St. Jude's pacing leads
European regulators have granted St. ...Learn More
FDA study finds nerve stimulators can help treat migraines
An FDA study found that the Cerena transcranial magnetic stimulator and the Cefaly transcutaneous electrical ...Learn More
Trial begins for Rotation Medical's rotator cuff device
A postmarket trial has been launched by Rotation Medical to test the use of its rotator cuff device in treating patients ...Learn More
3 new sizes of Covidien's ultrasonic dissectors OK'd by FDA
Covidien has secured FDA clearance for the 13-, 26- and 48-centimeter sizes of the company's Sonicision Cordless Ultrasonic ...Learn More
AdvaMed, PhRMA, BIO: Disclosure of doc payments needs more context
The CMS needs to provide more clarity on what information about payments to physicians will be posted and how it will be ...Learn More
FDA panel sets review date for VertiFlex's spinal device
An FDA panel of advisers will convene on Dec. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Art is a marriage of the conscious and the unconscious.
Jean Cocteau, French ...Learn More
Bill that includes proposal to repeal device tax clears House
The Jobs for America Act, which includes a proposal to revoke the 2.3% medical device tax and refund payments made since the ...Learn More
For more:
Read the AdvaMed press release outlining the collective support being given by AdvaMed, the Medical Imaging & Technology ...Learn More
Nexstim pushes toward IPO, advances brain technologies
Nexstim plans an initial public offering on the Nasdaq OMX First North market, with listing on both First North Sweden and ...Learn More
ILife signs genetic testing deal with OvaGene
India-based iLife Discoveries has entered into a research and marketing deal with OvaGene for undisclosed terms. ...Learn More
Chinese investor pumps $25M into iHealth Lab
Xiaomi Ventures, the venture capital unit of Chinese smartphone company Xiaomi, has made a $25 million investment in iHealth ...Learn More
Intellijoint's hip-replacement device used for first time in U.S.
A doctor at Massena Memorial Hospital in New York has performed the first hip-replacement surgery in the U.S. ...Learn More
Study of Intersect's device in frontal-sinusitis patients kicks off
Intersect ENT has begun patient enrollment in a clinical study to test the use of its Propel Mini system in patients with ...Learn More
Device facilitates rapid delivery of stem cells into the heart
Doctors at the University of Frankfurt's German Cardiology Center have used TRI Medical's ND Infusion Catheter to rapidly ...Learn More
16-slice CT scanner from Siemens gets FDA OK
Siemens Healthcare has secured FDA clearance for its Somatom Scope 16-slice CT scanner. ...Learn More
Roche's glucose monitor with insulin calculator wins FDA nod
The FDA has cleared Roche to market its Accu-Chek Aviva Expert device, which is said to be the first diabetes-management ...Learn More
FDA OK sought by Invictus for newborn-cranial-pressure device
Invictus Medical has submitted to the FDA an application seeking 510(k) clearance for its Gel Shield system, designed to ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It's not what you look at that matters, it's what you see.
Henry David Thoreau, American writer and ...Learn More
Intuitive Surgical gets wider FDA OK for robotic systems
The FDA has granted Intuitive Surgical expanded clearance for its da Vinci S and Si robotic surgery devices. ...Learn More
Avant Diagnostics to be purchased by American Liberty Petroleum
American Liberty Petroleum has agreed to pay an undisclosed amount to acquire Avant Diagnostics, maker of the OvaDx test ...Learn More
Mass. spinal device firm advances $20.9M funding round
A funding round aiming for $20.9 million has brought in $17.3 million for Intrinsic Therapeutics. ...Learn More
FlowMetric sets up flow cytometry-based companion Dx unit
FlowMetric has established a new subsidiary that will focus on developing companion diagnostic tests using flow cytometry ...Learn More
Industry veteran named CEO of Insulet
Patrick Sullivan has been appointed to serve as the new CEO of insulin-pump-maker Insulet. ...Learn More
Report: Global orthopedic-power-tools market could hit $1.6B in 2020
A MarketOptimizer report forecasts that the worldwide market for orthopedic power tools will increase from $1.4 billion in ...Learn More
MiMedx grants allograft-distribution rights to Zimmer
MiMedx has agreed to allow Zimmer to market its dehydrated human amnion/chorion membrane allografts on a private-label ...Learn More
Upgraded 3D imaging tool from EOS lands FDA clearance
The FDA has cleared EOS Imaging to market version 1.6 of the company's sterEOS 3D imaging tool. ...Learn More
AdvaMed says FDA's medtech proposal could change device classification process
AdvaMed has expressed concern over the FDA's proposal to update its rules governing medical device classification and ...Learn More
FDA listing of Thermo's next-generation sequencing tech completed
The FDA registration of Thermo Fisher Scientific's Ion PGM Dx system as a Class II medical device has been finalized. ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
Vows made in storms are forgotten in calm.
Thomas Fuller, British ...Learn More
Medtronic agrees to sell ENT instrument lines for $60M
Medtronic has agreed to sell its Xomed and MicroFrance lines of ear, nose, throat and laparoscopic instruments to Integra ...Learn More
Blue Belt signs robotic-surgery deal with J&J unit
Blue Belt Technologies will combine its Navio robot-assisted surgery system with the SIGMA HP partial knee device of DePuy ...Learn More
Istomedica enters distribution partnership with OncoDNA
Istomedica has struck a deal to exclusively offer OncoDNA's molecular theranostics products on the Greek market. ...Learn More
GE Healthcare gets new chief technology officer
Dr. Jorg Debatin has been appointed to serve as vice president and chief technology officer of GE Healthcare. ...Learn More
EU approves Boston Scientific's deep brain stimulation device
European regulators have granted Boston Scientific the CE mark for its Vercise Deep Brain Stimulation System. ...Learn More
Metabolon strikes EU marketing deal for diabetes tests
Spanish biomedical company Metdia Biotech has entered into a marketing deal with Metabolon for undisclosed terms. ...Learn More
Kimberly-Clark readies Halyard Health medical device spinout
Halyard Health, the publicly traded, $1.6 billion spinout of Kimberly-Clark's medical device business, is slated to go live ...Learn More
Research aims to test use of Angle's CTC tech in ovarian cancer
Experts at the Medical University of Vienna in Austria are evaluating whether Angle's Parsortix diagnostics platform can be ...Learn More
Medtronic makes advanced balloon kyphoplasty device available
Medtronic said its next-generation balloon kyphoplasty device, designed to treat patients with vertebral compression ...Learn More
Wearable prostate coil introduced by ScanMed
A wearable MRI coil with antenna elements placed close to targeted anatomies has been unveiled by ScanMed of Resonance ...Learn More
FDA clears single-needle dialysis device from NxStage
The FDA has given 510(k) clearance for NxStage's OneSite, a portable single-needle dialysis device that is intended to ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. – 2:00 p.m. ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
A thing well done is worth doing.
Hugh Leonard, Irish ...Learn More
Former CEO seeks possible takeover of Alere for $3.82B
A regulatory filing shows that former Alere CEO Ron Zwanziger is leading a stockholder effort to acquire the company for ...Learn More
Medtronic, Ortho Kinematics sign spinal Dx test marketing deal
Medtronic has agreed to offer Ortho Kinematics' Vertebral Motion Analysis assay to spinal surgeons under a deal reached ...Learn More
Mich. startup developing 3D-printed bone scaffold gets $2M boost
Tissue Regeneration Systems has received $2 million in a round of financing from existing backers. ...Learn More
Abbott gains rights to sell HIV genotyping software
Abbott Laboratories has received non-exclusive rights from Advanced Biological Laboratories to sell its HIV genotypic data ...Learn More
Former OptiMedica executive tapped to lead Delphinus
Mark Forchette has been appointed to serve as president and CEO of Delphinus Medical Technologies, which develops ...Learn More
ASEAN members agree to adopt medtech directive by end of 2015
A deal has been reached among the 10 countries that make up the Association of Southeast Asian Nations to adopt the ASEAN ...Learn More
Study shows positive results for Boston Scientific's heart valve
Boston Scientific's Lotus transcatheter aortic valve implant demonstrated promising results in a clinical study involving ...Learn More
U.S. awards InDevR $14.7M to develop influenza test
The U.S. ...Learn More
Women's health ultrasound scanner introduced by Samsung
The WS80A with Elite ultrasound scanner, designed for women's health diagnosis, was showcased by Samsung at a recent ...Learn More
House to vote on jobs package with provision to repeal device tax
A package of jobs bills set for consideration in the House this week includes a provision that would strike down the 2.3% ...Learn More
For more:
Read the complete statement from AdvaMed President and CEO Stephen Ubl about the House jobs ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Don't aim for success if you want it; just do what you love and believe in, and it will come naturally.
David Frost, British ...Learn More
Danaher to acquire Nobel Biocare for $2.2B
Danaher has agreed to pay about $2.2 billion to purchase Nobel Biocare, a dental-implant maker, in a deal said to be the ...Learn More
$50M shelf registration filed by Vermillion
A shelf registration has been filed by Vermillion with the goal of selling $50 million in stocks or related securities over ...Learn More
From hearts and bones to eyes and ears: VCs shift focus
Venture firms are investing more in treatments for blindness and hearing loss, according to The Wall Street Journal. ...Learn More
InSightec receives $12.5M from Chinese investors
A group of Chinese investors has pumped $12.5 million into InSightec, according to Elbit Medical Technologies, which owns a ...Learn More
Calif. Dx firm sets up shop in Europe
California-based Advanced Cell Diagnostics, which has developed a research-use-only in situ RNA detection test, has ...Learn More
Covidien kicks off embolization, stroke device studies
Covidien has begun patient enrollment in an FDA investigational device exemption trial of its Pipeline system, an ...Learn More
Partnership aims to develop early breast cancer Dx test
U.S.-based OncoCyte and U.K.-based Abcodia are collaborating to create a diagnostic test for early detection of breast ...Learn More
Medtronic announces U.S. release of wireless heart monitor
Medtronic said its SEEQ Mobile Cardiac Telemetry System, which won FDA clearance earlier this year, is available ...Learn More
Device uses magnets to remove toxins from blood
Scientists at the Wyss Institute for Biologically Inspired Engineering in Boston have designed a device inspired by the ...Learn More
U.S., EU regulators OK St. Jude's OCT imaging technology
A device developed by St. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
I have become my own version of an optimist. If I can't make it through one door, I'll go through another door, or I'll make a door. Something terrific will come no matter how dark the present.
Rabindranath Tagore, Indian ...Learn More
Symetis' transfemoral heart valve wins EU approval
Symetis has received the CE mark in Europe for its Acurate neo system, a transcatheter aortic valve implant delivered via a ...Learn More
Report: Ablation tech market could hit $2.41B by 2019
A MarketsandMarkets report predicts that the worldwide market for ablation devices could rise to about $2.41 billion in five ...Learn More
Stock sale could bring in $26.6M for Corindus
Corindus Vascular Robotics, which has operations in the U.S. ...Learn More
Medigus reports MUSE device trial results, wins funds
Medigus has announced that its MUSE, or Medigus Ultrasonic Surgical Endostapler, system demonstrated promising results in a ...Learn More
World's greenest companies include Abbott, Medtronic
Abbott has been recognized by the Dow Jones Sustainability World Index as among the companies with the most environmentally ...Learn More
EU OKs Biocartis' BRAF mutation test, molecular Dx platform
Biocartis has made its BRAF Mutation Test and Idylla molecular diagnostics platform available commercially in Europe, which ...Learn More
Researchers developing electronic skin to find lumps in breasts
A study in the journal ACS Applied Materials and Interfaces found that an electronic skin that is capable of "feeling" and ...Learn More
Beta-O2's artificial pancreas set to undergo clinical trial
Using funding from the Juvenile Diabetes Research Foundation, Beta-O2 is launching a clinical study of its ßAir device, a ...Learn More
Mitsubishi signs radiotherapy tech supply deal
The SAGA Heavy Ion Medical Accelerator in Japan has tapped Mitsubishi Electric to supply it with pencil-beam scanning ...Learn More
FDA clears pedicle screw device from ChoiceSpine
The FDA has given ChoiceSpine 510(k) clearance to market its THUNDERBOLT technology. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Look for a way to lift someone up. If that's all you do, it's enough.
Elizabeth Lesser, American ...Learn More
Mevion Medical plans to go public to raise $69M
Mevion Medical Systems seeks to obtain $69 million in an initial public offering. ...Learn More
Immunodiagnostic Systems strikes deal to acquire Diametra
Immunodiagnostic Systems has agreed to pay an undisclosed amount to purchase Diametra, an Italian firm specializing in ...Learn More
Wells Fargo provides $2M credit facility to Spine Pain Management
Wells Fargo Bank has granted Spine Pain Management a credit facility worth $2 million. ...Learn More
Former Intuitive Surgical exec takes the helm of MRI Interventions
Frank Grillo has been appointed to serve as CEO of MRI Interventions. ...Learn More
Advanced intraocular lens from AcuFocus gets CE mark
Regulators in Europe have given AcuFocus the CE mark for its IC-8 intraocular lens, designed to treat presbyopia in patients ...Learn More
Abbott unit could open manufacturing plant in Malaysia by 2015
Abbott Medical Optics plans to establish its first manufacturing plant in Malaysia, which company executive Diane Beno said ...Learn More
Device said to diagnose disease in minutes could hit market in 2016
QuantuMDx introduced at TEDMED 2014 a prototype of a device that could be used to spot Ebola, malaria, HIV and other ...Learn More
Wrist-worn device used to detect Parkinson's symptoms
Global Kinetics has received clearance from the FDA for its Personal KinetiGraph device, to be worn on the wrist for ...Learn More
FDA clears balloon catheter from Medtronic
The FDA has given Medtronic 510(k) clearance to market the NC Euphora balloon catheter. ...Learn More
Device used during MRI-based brain surgery wins FDA nod
IMRIS has secured 510(k) clearance from the FDA to market its HFD rocker arm, which is used in conjunction with the firm's ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
It doesn't matter where you are coming from. All that matters is where you are going.
Brian Tracy, Canadian ...Learn More
Argon buys maker of soft-tissue biopsy instruments
Argon Medical Devices has agreed to purchase US Biopsy for an undisclosed amount. ...Learn More
Md. mitral heart valve device firm gets $3.2M funding boost
A round of financing led by Epidarex Capital has so far brought in $3.2 million for Harpoon Medical. ...Learn More
Kimberly-Clark gears up for medical-device-unit spinoff
By Nov. 1, Kimberly-Clark will split off its health care unit into a stand-alone entity known as Halyard Health. ...Learn More
Reapplix picks former Acrobot exec to serve as CEO
Graeme Brookes, who formerly led robotic-technology company Acrobot, has been tapped to serve as CEO of Reapplix. ...Learn More
EU, Canadian regulators approve J&J unit's stent graft
Regulators in Canada and Europe have granted Cordis, a Johnson & Johnson unit, the green light to market its Incraft AAA ...Learn More
HART CEO David Green on the transformative potential for regenerative medicine
David Green tells MassDevice.com about the decision to split Harvard Bioscience and Harvard Apparatus Regenerative ...Learn More
U.S. study of Medtronic's repositionable heart valve kicks off
Medtronic has begun patient enrollment in a U.S. ...Learn More
Caprion gets Fox Foundation grant for Parkinson's biomarkers research
The Michael J. ...Learn More
Advanced ultrasound scanner released by Analogic
Analogic said its ultrasound scanner that builds on the firm's TriCore architecture is available commercially in specific ...Learn More
Tyber announces limited launch of trauma screw implant
Tyber Medical is making its headless cannulated trauma screw implant available to surgeon advisers and private-label ...Learn More
FDA clears 2 surgical plating systems from EDGE Orthopaedics
The FDA has cleared EDGE Orthopaedics to market a pair of surgical plating technologies. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. – 2:00 p.m. ...Learn More
From what we get, we can make a living; what we give, however, makes a life.
Arthur Ashe, American professional tennis ...Learn More
Medtech sector a boon for N.Y.'s economy, report says
The medical device industry in New York is booming, providing more than 74,000 jobs statewide, with around 28,500 of them in ...Learn More
Opticul Diagnostics to receive $450K investment from BATM
Israeli firm BATM Advanced Communications has agreed to acquire a 20% stake in Opticul Diagnostics for as much as $450,000 ...Learn More
Mich. awards $300K in training grant to Orchid Orthopedic
Orchid Orthopedic Solutions, which develops orthopedic implants and surgical instruments, has been awarded a grant worth ...Learn More
Maker of osteoporosis Dx device wins innovation award
Bone Index is among this year's recipients of the Nordic Stars Award, which was presented at the recent Nordic Life Science ...Learn More
China OKs robotic surgery device from Mazor
Mazor Robotics has received the green light in China to market its Renaissance system, a robot-assisted surgery device used ...Learn More
Hamilton gets CE mark for transport ventilator with neonatal option
The HAMILTON-T1 transport ventilator, which incorporates neonatal functionality, has obtained CE mark approval in Europe. ...Learn More
Biodesix wins reimbursement coverage for lung cancer assay
Highmark has agreed to provide reimbursement coverage for Biodesix's VeriStrat assay. ...Learn More
Titan Spine offers warranty for spinal fusion devices
Titan Spine has issued a new warranty covering its Endoskeleton interbody fusion systems. ...Learn More
New test detects antibiotic-resistant infections in hours
Oregon State Public Health Laboratory researchers have designed the Carba NP test to detect carbapenem-resistant ...Learn More
FDA's plan to regulate LDTs undergoes congressional scrutiny
A hearing held Tuesday by a House subcommittee focused on the FDA's proposal to subject lab-developed tests to regulatory ...Learn More
For more:
AdvaMedDx Executive Director Andrew Fish testified before a House subcommittee Tuesday in support of FDA regulation of ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Talent is God-given; be humble. Fame is man-given; be thankful. Conceit is self-given; be careful.
John Wooden, American basketball ...Learn More
Coronary-stent manufacturer obtains $20M in financing
A funding round has pulled in $20 million for Tryton Medical, which specializes in stents used to treat patients with ...Learn More
Breas expands ventilator offering with B&D Electromedical buy
Breas Medical has struck a deal to acquire the U.K.'s only ventilator manufacturer, B&D Electromedical, for an undisclosed ...Learn More
Former QSpine exec named U.K. sales manager of Aurora Spine
Mike Coupland has been appointed to serve as national sales manager for Aurora Spine's operations in the U.K. ...Learn More
Codman Neuro scores regulatory wins in Asia-Pacific region
Codman Neuro, a unit of Johnson & Johnson's DePuy Synthes business, has received the go-ahead to market its Revive SE device ...Learn More
Study: Patch with microscopic vaccination needles painless, effective
Researchers in Cork, Ireland, have developed a vaccination technique that uses a small patch with about 100 microscopic ...Learn More
GenetWorx gains OK to offer drug-response test panel in N.Y.
New York has certified GenetWorx to offer genetic testing services using its DNA Drug-Response Panel to in-state patients. ...Learn More
Diagnostic tool designed to ID cancer in blood samples
Exosome Sciences and its parent company, Aethlon Medical, have created a diagnostic tool that they say could spot several ...Learn More
Device to stop bleeding during GI endoscopies hits U.S. market
Olympus is making its QuickClip Pro system available commercially in the U.S., which comes on the heels of an FDA clearance ...Learn More
FDA grants orphan drug designation for HART-Trachea
Harvard Apparatus Regenerative Technology has received orphan drug designation from the FDA for its HART-Trachea, a ...Learn More
New patent issued to Ceterix Orthopaedics
Ceterix Orthopaedics has expanded its patent portfolio with one that covers its methods and technologies, including the ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
I must govern the clock -- not be governed by it.
Golda Meir, former Israeli prime ...Learn More
Recalls of medical devices declined dramatically in Q2, report says
A Stericycle report found that during the second quarter, the industry saw 275 medical device recalls affecting 148 firms, ...Learn More
Mass. maker of type 2 diabetes device obtains $40M
A Series C financing round headed by Mithril Capital Management has brought in $40 million for Fractyl Laboratories. ...Learn More
Md. migraine-device firm advances $6.6M funding round
ENeura has secured $5.8 million from 67 backers, bringing the company closer to its financing target of $6.6 million. ...Learn More
Stock offering brings in $3M for Integrity Applications
A private shares offering has pulled in $3 million for Integrity Applications. ...Learn More
Ariz. molecular Dx firm eyes $800K from stock sale
A regulatory filing shows that HTG Molecular Diagnostics looks to obtain $800,000 in a private shares offering that ...Learn More
Japanese firm unveils 2 advanced imaging monitors
Japan-based Totoku has introduced the CCL210 and CCL242 monitors, the latest addition to its i2 product line. ...Learn More
Study shows positive results for Biotronik's drug-eluting stent
A clinical study appearing in The Lancet found that Biotronik's Orsiro biodegradable polymer-based stent, which releases the ...Learn More
Acute-kidney-injury test from Astute Medical gets FDA OK
The FDA has given Astute Medical the go-ahead to market its NephroCheck test under the agency's de novo premarket review ...Learn More
FDA approval sought by Cerapedics for i-FACTOR bone graft
Cerapedics has submitted to the FDA an application seeking premarket approval for the i-FACTOR Peptide Enhanced Bone Graft. ...Learn More
APEX Medical, ResMed reach patent settlement deal
APEX Medical and ResMed have agreed to settle a patent dispute for undisclosed terms. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Progress is impossible without change, and those who cannot change their minds cannot change anything.
George Bernard Shaw, Irish ...Learn More
Avedro expands corneal device footprint with Iroc Innocross buy
Avedro has agreed to pay an undisclosed sum to acquire Iroc Innocross, the Swiss maker of a cross-linking device used to ...Learn More
Veracyte enters lung cancer Dx market with Allegro acquisition
Veracyte has agreed to pay $21 million in cash and company stock to buy Allegro Diagnostics, which has developed a gene ...Learn More
Sengenics signs prenatal test distribution deal with Sequenom
Sengenics has agreed to bring Sequenom's VisibiliT assay to Indonesia, Thailand and Brunei under an exclusive deal reached ...Learn More
Industry veteran named consumer GM at NeuroMetrix
Frank McGillin, who previously worked at Johnson & Johnson and Philips Oral Healthcare, has been selected to serve as senior ...Learn More
EU grants CE mark for Cepheid's trichomoniasis test
The Xpert TV trichomoniasis test has obtained CE mark approval in Europe, according to Cepheid, which developed the ...Learn More
Amoy Diagnostics wins approval for 2 IVD kits in China
Amoy Diagnostics has been granted approval to market its AmoyDx ROS1 and AmoyDx ALK/ROS1 in vitro diagnostic test kits in ...Learn More
Trial enrollment for Claret's cerebral protection device completed
Claret Medical has completed patient enrollment in a U.S. ...Learn More
Ultrasound scanner from Esaote scores FDA clearance
The FDA has cleared Esaote North America to market its MyLab Six ultrasound technology for use in general, cardiovascular, ...Learn More
Stereotaxis receives FDA clearance for catheter device
The FDA has granted Stereotaxis 510(k) clearance to market its Vdrive robotic navigation system with V-Loop variable loop ...Learn More
FDA OKs tinnitus device from Otoharmonics
Otoharmonics has been cleared by the FDA to market its Levo System, designed to provide temporary relief for patients with ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Without a humble but reasonable confidence in your own powers you cannot be successful or happy.
Norman Vincent Peale, American minister and ...Learn More
Medtronic's next-gen heart valve gains approval in Europe
Medtronic has received CE mark approval to market its CoreValve Evolut R system in Europe. ...Learn More
Calif. maker of presbyopia device obtains $21M
California-based AcuFocus has secured $21 million in a round of financing from existing investors, including Medtronic. ...Learn More
Impedimed scores reimbursement win for lymphoedema Dx device
The American Medical Association has issued a code expanding reimbursement coverage for Impedimed's device used to detect ...Learn More
BSD Medical closes hyperthermia-device deal with Linden Bioscience
Linden Bioscience has purchased another BSD-2000 hyperthermia device from BSD Medical, the fourth such purchase made by the ...Learn More
EU approves Abbott's wearable blood glucose monitor
Abbott has earned the CE mark in Europe for its FreeStyle Libre system, a wearable device that can monitor blood glucose ...Learn More
Roche earns CE mark for blood and plasma donor screening systems
Roche has obtained the CE mark for its cobas 6800/8800 systems, two fully automated molecular testing systems for blood and ...Learn More
Medtech trends: The most talked-about device makers in August 2014
MassDevice.com looks at the Internet chatter surrounding the medical device industry with some of the most searched-for ...Learn More
Scientists develop rapid, low-cost test for sickle cell disease
Harvard University researchers have designed a faster and less-expensive test for detecting sickle cell disease that can ...Learn More
Hip replacement device from Ortho Development wins FDA nod
The FDA has given Ortho Development 510(k) clearance to market its Alpine system for use during total hip arthroplasty and ...Learn More
FDA urged to improve role of medtech registries in U.S.
Several groups are calling on the FDA to spur the development of registries to monitor medical devices. ...Learn More
U.S., EU regulators OK K2M's MESA Hooks system
The FDA has cleared K2M to market its MESA Hooks technology, designed to offer a low-profile implant option to the company's ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Life is not a matter of holding good cards, but of playing a poor hand well.
Robert Louis Stevenson, Scottish ...Learn More
Boston Scientific wraps up $415M purchase of Bayer Interventional
The acquisition of Bayer Interventional by Boston Scientific for $415 million has been finalized. ...Learn More
Invacare agrees to $23M sale of Altimate Medical business
Invacare has agreed to sell its Altimate Medical unit, which develops standing-assistance devices for patient ...Learn More
Former ArthroCare exec takes the helm of Bluegrass Vascular
Gabriele Niederauer, who most recently served as vice president of research and development at ArthroCare's ENT-Sinus unit, ...Learn More
EU approves influenza, RSV test from Cepheid
Cepheid has earned the CE mark to market its Xpert Flu/RSV XC test in Europe. ...Learn More
Cancer Genetics wins CE mark for cervical cancer test
European regulators have granted Cancer Genetics the CE mark, allowing the firm to market its FISH-based HPV-associated ...Learn More
St. Jude's FFR tech shows promise in coronary artery disease trial
A study in the New England Journal of Medicine showed promising results for St. ...Learn More
Advanced Biological enters Dx development deal with Mayo Medical
Advanced Biological Laboratories has agreed to work with Mayo Medical Laboratories to create next-generation sequencing ...Learn More
Expert creates prototype of a batteryless pacemaker
A Swiss scientist has developed a prototype of a cardiac pacemaker that can operate without the need for batteries. ...Learn More
FDA OKs 3D breast imaging device from GE Healthcare
The FDA has given GE Healthcare approval to market its SenoClaire system, a digital breast tomosynthesis system that ...Learn More
Bunion correction device from Arthrosurface gains FDA clearance
The FDA has cleared Arthrosurface to market its KISSloc Suture System, a tiny plate and suture implant designed to treat ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
The art of being wise is the art of knowing what to overlook.
William James, American philosopher and ...Learn More
Calif. neurostimulation device firm eyes $50M in IPO
NeuroSigma is looking to obtain $50 million in an initial public offering. ...Learn More
$100M shelf registration filed by NanoString Technologies
A shelf registration has been filed by NanoString Technologies with the intent of selling $100 million in stocks or related ...Learn More
Diagnostic test-maker bought by Orgentec for about $16M
Orgentec Diagnostika agreed to pay approximately $16 million to purchase Corgenix Medical, a Broomfield, Colo.-based firm ...Learn More
Debt funding round brings in up to $16M for HTG Molecular
Silicon Valley Bank and Oxford Finance have granted HTG Molecular Diagnostics a loan worth as much as $16 million. ...Learn More
Medtech consultancy firm to set up office, hire 30 in Boston
Regulatory and Quality Solutions, which provides consultancy services to medical device-makers, has announced plans to set ...Learn More
Comments sought for Brazil's device, drug trial proposal
Anvisa, Brazil's medtech regulator, has issued a draft document outlining the agency's new requirements and procedures for ...Learn More
Pentagon awards $255M medical-supply contract to Arthrex
The Department of Defense has awarded Arthrex a contract to supply the department's military units and federal civilian ...Learn More
Clinical trial begins for Kona Medical's hypertension device
Kona Medical has initiated a clinical study evaluating its Surround Sound system, an ultrasound-based renal denervation ...Learn More
Advanced finger pulse oximeter from Nonin gets FDA OK
The FDA has given Nonin Medical 510(k) clearance for its finger pulse oximeter that incorporates the company's PureSAT ...Learn More
FDA OKs CorMatrix's porcine tissue-based surgical envelope
CorMatrix said its CanGaroo ECM Envelope, a pig tissue-derived cellular matrix designed to secure pacemakers and other ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
No matter how busy you are, you must take time to make the other person feel important.
Mary Kay Ash, American ...Learn More
Covidien makes 2nd acquisition this month
Covidien has signed a deal to acquire Sapheon, along with its VenaSeal system used to treat chronic venous insufficiency and ...Learn More
Surgical Frontiers to pump $7M into surgical device startups
Surgical Frontiers has raised an investment fund worth $7 million. ...Learn More
Varian's facility expansion could add 1K jobs in Utah over 20 years
Varian Medical Systems is adding 135,000 square feet of space to its facility in Salt Lake City, where the company ...Learn More
Pacific Edge enters partnership for bladder cancer Dx study
The Southern California Permanente Medical Group has agreed to work with Pacific Edge to investigate the latter's Cxbladder ...Learn More
Industry veteran tapped to lead St. Teresa Medical's clinical affairs
St. Teresa Medical has tapped Rudy Padua, a medtech industry veteran, to serve as its clinical affairs director. ...Learn More
Masimo gains OK for infant hemoglobin monitor in Europe, Japan
Masimo has received approval to market its rainbow DCI-mini system in Europe and Japan, and is preparing for a limited ...Learn More
Postmarket trial of Medtronic's AdaptivCRT algorithm kicks off
Medtronic has initiated a postmarket trial evaluating its AdaptivCRT algorithm, designed to allow cardiac resynchronization ...Learn More
Vital Connect's biosensor patch gets FDA OK for in-home use as patient monitor
The FDA has cleared Vital Connect to market its HealthPatch MD system for in-home use to monitor patients who have just been ...Learn More
Pediatric scoliosis device from Medtronic wins FDA nod
The FDA has cleared Medtronic to market its SHILLA Growth Guidance System, designed to offer a better alternative to ...Learn More
FDA clears veno-venous cannula from CardiacAssist
CardiacAssist has been cleared by the FDA to market its PROTEK Duo system, a veno-venous cannula used during extracorporeal ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
SmartBrief will not publish Monday
In observance of Labor Day in the U.S., AdvaMed SmartBrief will not publish Monday. Publication will resume ...Learn More
A hero is one who knows how to hang on one minute longer.
Novalis, German ...Learn More
Medtronic continues acquisition trail with NGC Medical buy
Medtronic has acquired NGC Medical, an Italian firm that manages intensive care units, operating rooms and cardiovascular ...Learn More
Ill. maker of esophageal cooling device closes $1.5M round
A Series A round of financing has pulled in $1.5 million for Illinois-based Advanced Cooling Therapy, which is preparing to ...Learn More
Calif. molecular Dx firm boosts revenue in Q2
California-based CareDx generated $6.8 million in revenue during the second quarter, up from $5.5 million during the same ...Learn More
Q3 revenue for BioReference Laboratories hits record high
BioReference Laboratories said its revenue hit a record high in the third quarter, generating $222.1 million during the ...Learn More
S. Korean firm to make Ebola virus test kit available in Africa
A molecular diagnostic kit that can spot an Ebola virus subtype tied to recent outbreaks in Africa will be released by ...Learn More
Metastatic brain cancer patient in Israel treated with Brainlab's tech
A 62-year-old patient in Israel has been treated for metastatic brain cancer using Brainlab's Automatic Brain Metastases ...Learn More
Wound care by the numbers: Q&A with Alliqua CEO Dave Johnson
Medtech veteran Dave Johnson has been with Alliqua Biomedical for less than two years, during which time he's overseen a ...Learn More
Serum-based test for preeclampsia in the works
Carmenta Bioscience, a spinoff of Stanford University, is working on a serum-based test that can be used to detect ...Learn More
Brain aneurysm device from MicroVention wins FDA nod
MicroVention, a Terumo unit, has received FDA approval to market its Low-Profile Visualized Intraluminal Support Device. ...Learn More
FDA OKs Hansen Medical's robotic arm transport technology
Hansen Medical has been cleared by the FDA to market its Magellan Transport System, which could hit the market in the third ...Learn More
FDA clears St. Jude Medical's neuromodulation facility in Texas
The FDA has cleared St. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Believe you can and you're halfway there.
Theodore Roosevelt, 26th U.S. ...Learn More
Medtronic pays $200M for deep brain stimulation device firm
Medtronic has struck a deal to acquire Sapiens Steering Brain Stimulation, a Dutch company developing a next-generation ...Learn More
Tenn. catheter device firm pushes cap on Series B funding round
Advanced Catheter Therapies has increased the financing target of its Series B round from $3 million to $4.5 million. ...Learn More
Mass. vaccine delivery device maker wins Technology Pioneer award
The World Economic Forum has named Vaxxas as one of this year's recipients of the 2015 Technology Pioneer award. ...Learn More
Amedica appoints new board chairman
Dr. B. ...Learn More
Expanding Orthopedics reports first use of FLXfit system in France
A doctor in France has carried out the first spinal procedure using Expanding Orthopedics' FLXfit system, which was cleared ...Learn More
Asuragen signs cancer panel deal with Janssen Diagnostics
Asuragen has agreed to make its SuraSeq next-generation sequencing cancer panels available to Janssen Diagnostics' customers ...Learn More
Smartphone-based device monitors glaucoma
Israeli researchers have created an implantable sensor that uses a smartphone camera to measure pressure in the eyes of ...Learn More
3D-printed implant restores neck mobility in Chinese boy with vertebral tumor
A 12-year-old boy in China who suffered a spinal cord injury and later developed a vertebral tumor regained motion in his ...Learn More
FDA panel to take another look at Boston Scientific's stroke device
A panel of FDA advisers will convene on Oct. ...Learn More
MR systems from Toshiba certified for use on Air Force Network
The Air Force has granted Toshiba America Medical Systems approval-to-operate status for its Vantage Titan 3- and 1.5-Tesla ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Management is doing things right; leadership is doing the right things.
Peter Drucker, Austrian-American writer and management ...Learn More
Medtronic gains FDA approval for personalized pacemaker
The FDA has granted Medtronic approval to market its Viva CRT-P system for use in treating patients with heart failure or ...Learn More
Mass. senior care tech firm obtains $10M in fresh capital
Healthsense, which develops remote monitoring devices for senior care, has secured $10 million in its latest funding round. ...Learn More
Affymetrix taps Greenwood Genetic Center to offer CytoScan Dx test
Affymetrix has agreed to allow Greenwood Genetic Center to offer its CytoScan Dx Assay, which was cleared by the FDA earlier ...Learn More
Exact Sciences' colorectal cancer test to be offered by Mayo Clinic
Exact Sciences has announced that its Cologuard test, which received approval from the FDA earlier this month, will be ...Learn More
Medtech sector struggling to adopt digital technology, report finds
The medical device industry appears to be lagging behind other sectors in terms of digital technology adoption, according to ...Learn More
EU updates CE mark for Kips Bay Medical's surgical mesh
European regulators have revised the CE mark approval of Kips Bay Medical's eSVS Mesh system. ...Learn More
Global market for advanced orthopedic tech could hit $42.2B in 5 years
The worldwide market for advanced orthopedic systems rose to about $36.4 billion this year and is likely to grow to $42.2 ...Learn More
Device could remove need for open-heart procedures
Irish and U.S. researchers have created a device that they say could eliminate the need for open-heart procedures. ...Learn More
Aura sleep-assist system from Withings hits market
Withings said its Aura system, which uses a sensor to monitor movement, breathing and heart rate while the person is asleep, ...Learn More
FDA clears 2 blood glucose monitors from Nipro
The FDA has cleared Nipro Diagnostics to market its True Metrix Pro and True Metrix self-monitoring blood glucose systems, ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
The pessimist complains about the wind; the optimist expects it to change; the realist adjusts the sails.
William Arthur Ward, American ...Learn More
Covidien boosts vascular tech offering with Reverse Medical buy
Covidien has agreed to pay an undisclosed sum to purchase Reverse Medical, along with its vascular device portfolio. ...Learn More
Fla. cancer genetic testing firm raises $34.6M from stock sale
Florida-based NeoGenomics, which specializes in cancer genetic screening services, has obtained net proceeds of $34.6 ...Learn More
Corgenix signs companion Dx development deal with Eli Lilly
Regulatory filings indicate that Colorado-based Corgenix Medical, which specializes in deadly-virus-detection tests, has ...Learn More
French government awards eye implant contract to Second Sight
The French Ministry of Health has awarded Second Sight Medical a financial contract to provide its Argus II retinal implant ...Learn More
Canada OKs IMRIS' surgical theater with advanced MRI
Health Canada has given IMRIS the go-ahead to market its Visius surgical theater incorporated with an advanced version of ...Learn More
Turkey approves VuCOMP's breast cancer detection software
Turkish regulators have given VuCOMP the green light to sell its M-Vu Breast Density software and M-Vu CAD tools in that ...Learn More
Report: Orthopedic-instrument market poised for more growth in China
A report from Research in China predicts continued growth for the Chinese market for orthopedic instruments, which is ...Learn More
Claret Medical obtains $18 million for development of blood filter
Claret Medical has raised $18 million in a Series B funding round. ...Learn More
Ceiling-mounted DR tube introduced by Carestream
A ceiling-mounted tube option is being offered by Carestream Health for its DRX-Ascend digital radiography technology. ...Learn More
Senator calls for eliminating device tax amid collection difficulties
A Treasury Department report citing issues with collection of the medical device tax is another example of problems with the ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Don't be afraid to give up the good to go for the great.
John D. Rockefeller, American ...Learn More
New size of Direct Flow Medical's TAVI device gains CE mark
European regulators have granted Direct Flow Medical the CE mark for a 23-millimeter size of its transcatheter aortic valve ...Learn More
Prostate cancer test boosts first half 2014 revenue for MDxHealth
Belgium-based molecular diagnostics company MDxHealth generated $4.8 million in revenue during the first half of this year, ...Learn More
Baxter's facility expansion in Ala. could create 200 jobs
Baxter International is investing $300 million to add 230,000 square feet of space to its manufacturing facility in Opelika, ...Learn More
EU notified body plans program of surprise audits
As many as 300 unannounced audits of medical device manufacturers around the world are being planned by BSI Group, and a ...Learn More
Covidien sets up training facility in Brazil
Covidien has announced the opening of its 3,000-square-meter training facility in Sao Paulo, Brazil. ...Learn More
Implantable tissue scaffolds stimulate bone growth
Massachusetts Institute of Technology researchers are developing a bone repair scaffold that releases embedded growth ...Learn More
Sedia Biosciences receives NIH grant for rapid HIV-1 test
The National Institutes of Health's National Institute of Allergy and Infectious Diseases has awarded Sedia Biosciences a ...Learn More
A-fib algorithm used with AliveCor's smartphone ECG wins FDA nod
The FDA has given AliveCor 510(k) clearance to market an algorithm that can accurately identify the presence of atrial ...Learn More
Covidien gets FDA OK for changes to PTFE coating production process
Changes made by Covidien to its polytetrafluoroethylene coating production process have been approved by the FDA. ...Learn More
FDA OKs Philips' 3D planning tool for TAVI procedures
The FDA has cleared Philips Healthcare to market its 3D planning application, designed to help surgeons perform ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Discussion is an exchange of knowledge; argument an exchange of ignorance.
Robert Quillen, American ...Learn More
Pilot initiative will test tools for streamlining medtech regulatory processes
The FDA has released guidelines governing its pilot program to develop tools for streamlining the premarket review and ...Learn More
Dx services boost revenue for Source BioScience in first half of 2014
Source BioScience posted $21.3 million in revenues during the first half of this year, up 46% over the same period last ...Learn More
Hologic tapped to offer fracture evaluation tool in Canada, U.S.
Hologic has agreed to market in the U.S. ...Learn More
Antibacterial gel could eliminate resistant superbugs
A new antibacterial gel composed of peptides has shown promise in killing drug-resistant bacteria including Pseudomonas ...Learn More
Device helps uncover how malaria parasites invade red blood cells
Wellcome Trust Sanger Institute scientists used laser optical tweezers to better understand malaria's invasion of red blood ...Learn More
Kronus' autoantibody test for type 1 diabetes OK'd by FDA
Kronus has received FDA clearance to market its Zinc Transporter 8 Autoantibody test, which can differentiate between type 1 ...Learn More
Study shows faster FDA premarket device approvals this year
An Evaluate Group study found that the number of first-time premarket approvals issued by the FDA rose from nine during the ...Learn More
IRS struggling with medical-device tax under Affordable Care Act
The medical-device tax that is part of the Affordable Care Act is only raising 75% of expected revenue, in part because the ...Learn More
Intraocular lenses to get year reprieve for UDI compliance
Companies developing Class III intraocular and contact lenses have until Sept. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Be a yardstick of quality. Some people aren't used to an environment where excellence is expected.
Steve Jobs, American ...Learn More
VC firm to pump $110M into medtech, other health care firms
HealthQuest Capital has secured an investment fund worth $110 million. ...Learn More
Boston Scientific signs development deal with Asahi
Asahi Intecc in Japan has agreed to work with Boston Scientific to create enhanced fractional flow reserve wires that will ...Learn More
Roche signs epigenomic analysis tech deal with Garvan Institute
Roche has entered into a two-year deal with the Garvan Institute of Medical Research to jointly develop new technologies for ...Learn More
Nirmidas moves to commercialize fluorescence technology
Nirmidas Biotech has assembled $2 million for the commercialization of its fluorescence system for improved biomarker ...Learn More
Medtech applications relying on 8 EU notified bodies subject to audit in Australia
Lack of confidence in eight European medical device notified bodies has caused Australia's Therapeutic Goods Administration ...Learn More
Firm to advance lung cancer test in China with fresh capital
20/20 GeneSystems has received an undisclosed investment from BHC Center of Financial and Investment Business. ...Learn More
Remote monitoring outperforms usual care in HF patients
Data on heart failure patients showed that those who used Biotronik's Home Monitoring system for implantable ...Learn More
Device to treat temporomandibular joint pain gets FDA OK
The FDA has cleared TMJ Health to market a device that offers a better alternative to bite splints in treating ...Learn More
FDA clears 3D-printed facial implant
The FDA cleared Oxford Performance Materials' OsteoFab 3D-printed facial implant, which will be distributed globally by ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Most people say that it is the intellect which makes a great scientist. They are wrong: It is character.
Albert Einstein, German-American theoretical ...Learn More
LeMaitre hopes to boost vascular portfolio with Xenotis buy
LeMaitre Vascular has agreed to pay $7.7 million to acquire Xenotis, along with its Omniflow II biological graft. ...Learn More
Partners sought by ElectroCore to advance migraine tech to market
Piper Jaffray has been enlisted by ElectroCore to help the company find possible partners to bring its noninvasive vagus ...Learn More
Cancer Genetics closes $1.9M purchase of BioServe
Cancer Genetics has wrapped up its purchase of BioServe Biotechnologies, an India-based company providing next-generation ...Learn More
OsteoMed signs spinal device co-marketing deal with MedCom
OsteoMed and MedCom Advisors have agreed to jointly distribute OsteoMed's PrimaLOK SP Interspinous Fusion System as well as ...Learn More
Global orthopedic trauma fixation market could hit $9.4B in 6 years
A report from Persistence Market Research forecasts that the worldwide market for orthopedic trauma fixation systems could ...Learn More
Ultrasound scanner with dual probe released by GE
An advanced model of the Vscan ultrasound scanner has been introduced by GE Healthcare. ...Learn More
Image denoising software lands FDA clearance
The FDA has cleared Vital Images to market its Structure Preserving Diffusion software, a postprocessing filter used with ...Learn More
TAVI device used for first time in tricuspid valve replacement in U.S.
A patient with a failing tricuspid valve in her heart was turned down by one surgery center and told by another that she ...Learn More
CMS to hold back a third of data from Sunshine Act site due to inconsistencies
CMS spokesman Aaron Albright said by e-mail that the agency will withhold one-third of the data on payments from ...Learn More
FDA OKs Philosys' smartphone-based blood glucose monitor
The Gmate Smart Blood Glucose Monitoring System, developed by Philosys, has obtained 510(k) clearance from the FDA. ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
A good head and a good heart are always a formidable combination.
Nelson Mandela, former South African ...Learn More
Pentagon taps Abbott to develop TBI detection system in $19.5M deal
The Defense Department has awarded Abbott a $19.5 million contract to develop technology that could aid in the detection of ...Learn More
Stock sale could bring in $32.2M for NeoGenomics
NeoGenomics, which specializes in genetic testing, hopes to secure $32.2 million in an offering of company shares valued at ...Learn More
Industry veteran named sales and marketing VP at Volpara
Volpara Solutions, which develops breast imaging technology, has tapped Shawl Lobree to serve as vice president of its ...Learn More
Forum finalizes e-submission rules for IVDs, non-IVD devices
The International Medical Device Regulators Forum has issued final guidelines governing the electronic submission of ...Learn More
China proposes use of generic names for medical devices
A draft rule issued by the China Food and Drug Administration would prohibit the use of personal, company or brand names to ...Learn More
Cook Medical proceeds with study of peripheral stent in China
Cook Medical has begun patient enrollment for a clinical study in China of its Zilver PTX device, a drug-eluting stent used ...Learn More
Field trials underway for multifunctional diagnostic device
U.S. ...Learn More
Siemens' advanced image reconstruction tool gains FDA OK
A third-generation version of Siemens Healthcare's advanced modeled iterative reconstruction, or ADMIRE, software has won ...Learn More
BioTime lands FDA clearance for wound-healing gel
BioTime has been cleared by the FDA to market its Premvia HyStem hydrogel, designed to promote wound healing by ...Learn More
FDA warns Masimo over manufacturing practices at Calif. plant
The FDA has issued a warning letter to Masimo over manufacturing practice violations at its facility in Irvine, Calif. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Love involves a peculiar unfathomable combination of understanding and misunderstanding.
Diane Arbus, American photographer and ...Learn More
FDA offers guidelines on device ID rule, de novo review process
The FDA has released its final guidelines on how small firms may satisfy the unique device identifier rules, including ...Learn More
Silk Road Medical gets $15M boost for stroke prevention device
California-based Silk Road Medical has obtained $15 million in a funding round aiming for $22.5 million. ...Learn More
Interpace Diagnostics buys 2 microRNA tests from Asuragen
Interpace Diagnostics, a unit of PDI, has agreed to acquire Asuragen's miRInform Pancreas and Thyroid cancer tests for $8 ...Learn More
JenaValve picks former Edwards, Endologix exec as CTO
Stefan Schreck has been selected to serve as the new chief technology officer of JenaValve. ...Learn More
AdvancedCath sets up shop in Costa Rica
AdvancedCath has announced the launch of its 20,000-square-foot manufacturing plant in Costa Rica. ...Learn More
Irish Dx firm gains rights to Eiken's LAMP technology
Ireland-based HiberGene Diagnostics has entered into a licensing deal with Eiken Chemical for undisclosed terms. ...Learn More
Study: Hydrogel shows promise in preventing transplant rejection
U.S. ...Learn More
Blood test can detect mutations that cause malaria resistance
A study in The New England Journal of Medicine that examined blood samples of 1,240 people being treated for malaria in ...Learn More
2 wireless detectors unveiled by Rayence
Rayence has introduced a pair of wireless flat-panel detectors tailored for portable or in-room use. ...Learn More
Guidelines on home-use device development finalized by FDA
Final guidance issued by the FDA details the considerations for developing medical devices intended for in-home use by ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Everything that irritates us about others can lead us to an understanding of ourselves.
Carl Jung, Swiss ...Learn More
Second Sight Medical plans to go public to raise $32M
Second Sight Medical, maker of the Argus II eye implant designed to treat blindness in patients with retinitis pigmentosa, ...Learn More
Texas oncology firm obtains $11.8M in Series E financing
A Series E round of financing has pulled in $11.8 million for Castle Biosciences. ...Learn More
Proteocyte gets $554K in funding to boost sales of oral cancer test
A funding round has brought in $554,000 for Proteocyte Diagnostics, a Canadian firm specializing in molecular diagnostic ...Learn More
FirstVitals CMO named to Bacterin's board
Dr. David Goodman has been appointed to serve on the board of Bacterin International Holdings. ...Learn More
Scienion taps RayBiotech to bring its dispensing tools to China
RayBiotech has entered into a distribution deal with German firm Scienion for undisclosed terms. ...Learn More
Japan grants patents to IMRIS' intraoperative MRI tech
The Japan Patent Office has granted IMRIS three patents related to its intraoperative MRI technology integrated with the ...Learn More
CardioMEMS' 11-year payoff worth the wait for Boston Millennia Partners
Boston Millennia's managing general partner Dana Callow discusses the 11-year journey to bring CardioMEMs implantable heart ...Learn More
Exactech reports first use of femoral stem implant
A surgeon at Franciscan St. ...Learn More
Scientists create implantable device that produces insulin
Swiss scientists have created an implantable molecular device that features a sensor that measures blood pH levels and a ...Learn More
Mhealth app developer to seek FDA clearance for SnoreSounds
Appian Medical said it aims to secure 510(k) clearance from the FDA for its sleep apnea application called SnoreSounds and ...Learn More
Medtronic MiniMed reaches settlement deal with J&J unit
Johnson & Johnson has agreed to settle for undisclosed terms a patent lawsuit filed against its Animas division by Medtronic ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Defeat is not the worst of failures. Not to have tried is the true failure.
George Woodberry, American literary ...Learn More
Greatbatch to boost innovation efforts with CCC Medical buy
Greatbatch Medical has agreed to purchase CCC Medical Devices, a Uruguay-based company that develops implantable pulse ...Learn More
Investors pump $59M into Oxford Nanopore Technologies
A round of financing from current and new investors has brought in $59 million for Oxford Nanopore Technologies. ...Learn More
Seventh Sense gets $16M to develop painless blood-collection device
Cambridge, Mass.-based startup Seventh Sense Biosystems has received $16 million in new financing from a Series B funding ...Learn More
Ultrasound systems help fuel Q2 revenue growth for Mindray
Mindray Medical International posted $334.5 million in net revenue during the second quarter, an increase over $307.2 ...Learn More
Former JenaValve exec joins HeartWare as CMO
Dr. Katrin Leadley has been tapped to succeed Dr. David Hathaway as chief medical officer of HeartWare International. ...Learn More
Canada, Singapore OK molecular tests from IMDx
IMDx has received the go-ahead in Canada to market its test that can detect influenza A and B strains and the respiratory ...Learn More
ViaCyte raises $5.4 million to develop artificial pancreas
San Diego-based ViaCyte has received $5.4 million in private equity financing that will be used to support the clinical ...Learn More
Biodegradable wound dressing conforms to irregular shapes, seals out bacteria
Scientists at Tokai University in Japan have developed a nanosheet dressing made from biodegradable polyester that conforms ...Learn More
Dismissal of pain-pump lawsuit against 4 medtech firms upheld
A lower court's decision to dismiss a whistleblower lawsuit filed against Stryker, DJO Global, Orthofix and I-Flow has been ...Learn More
FDA OKs new device for preserving donated lungs
The FDA has approved the use of the XVIVO Perfusion System, a new device that preserves donated lungs for up to four hours ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
The mind is not a vessel to be filled but a fire to be kindled.
Plutarch, Greek ...Learn More
Retina's vision-correcting microchip lands German reimbursement
The German government has approved reimbursement coverage for Retina Implant's Alpha IMS technology, an implantable ...Learn More
Biosign agrees to $1.8M sale of medical device line
Biosign Technologies has agreed to divest itself of its Pulsewave line of medical devices and sell it to Global Life Safety ...Learn More
Smiths Medical's facility expansion could add 35 jobs in Conn.
Smiths Medical is spending $1 million to add 20,000 square feet of space to its existing facility in Southington, Conn., ...Learn More
ESensor detection tech boosts Q2 revenue for GenMark
GenMark Diagnostics generated revenue of $6.6 million during the second quarter, an increase from $5.2 million during the ...Learn More
EU approves Minimus Spine's ozone-delivery device
The TrioJection System, developed by Minimus Spine, has earned the CE mark in Europe. ...Learn More
Advanced Cell set to launch RNAscope products in Europe
Advanced Cell Diagnostics, which specializes in molecular diagnostics, has announced that its polymerase chain ...Learn More
Mount Sinai to bring Illumina's prenatal test to Ontario
Illumina has agreed to allow Mount Sinai Services to offer its Verifi test in Ontario for undisclosed terms. ...Learn More
Exact Sciences gains FDA approval for at-home colon cancer test
The FDA on Monday approved an at-home, DNA-based colorectal screening test from Exact Sciences that can spot genetic ...Learn More
A-fib patient in Utah sees wireless pacemaker as a lifesaver
Susan Thomas, a 72-year-old patient in Utah who was diagnosed with atrial fibrillation, has improved mobility after ...Learn More
Former senators tapped to lobby for Medtronic-Covidien merger
Medtronic has enlisted former Sens. John Breaux and Trent Lott to lobby for the company's pending merger with Covidien. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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I couldn't wait for success, so I went ahead without it.
Jonathan Winters, American ...Learn More
Medtronic gets FDA OK for 2 defibrillators, quadripolar lead
The FDA has granted Medtronic approval for its Viva Quad S and Viva Quad XT cardiac resynchronization therapy ...Learn More
LabStyle ramps up commercialization of blood glucose monitor, exec says
LabStyle Innovations is bolstering its effort to bring the Dario system, a smartphone-based device used to monitor blood ...Learn More
Cancer Dx tests boost Q2 revenue for Genomic Health
California-based Genomic Health posted $70.5 million in revenue during the second quarter, an increase from $63.7 million ...Learn More
CareFusion reports Q4 growth, plans $750M share repurchase program
CareFusion saw a 24% growth in sales and a 28% rise in profits during its fiscal fourth quarter. ...Learn More
New medtech rules in Germany include nonactive implant provisions
German regulators have adopted new medical device rules that include provisions governing nonactive implants. ...Learn More
Advanced pacemaker from Medtronic set to debut in India
The Viva cardiac resynchronization therapy-pacemaker, which earned the CE mark in Europe earlier this year, is being ...Learn More
Imaging provides new view of blood flow in the brain
Stanford University researchers have created a noninvasive high-resolution imaging technique that traces blood flow in the ...Learn More
2 mobile X-ray devices introduced by Meridian
Meridian Medical Systems has introduced the Paragon True-20 system, a mobile X-ray machine that comes with a lateral and ...Learn More
CMS delays launch of Sunshine Act reporting website
The CMS said Thursday that it will postpone the scheduled Sept. ...Learn More
Toshiba gains FDA clearance for vascular imaging tool
The FDA has cleared Toshiba America Medical Systems to market its Superb Micro-Vascular Imaging tool, which the company said ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Do the best you can in every task, no matter how unimportant it may seem at the time. No one learns more about a problem than the person at the bottom.
Sandra Day O'Connor, former U.S. Supreme Court ...Learn More
St. Jude Medical wraps up $200M purchase of NeuroTherm
St. ...Learn More
IPO brings in $57M for T2 Biosystems
T2 Biosystems, which specializes in MRI-based infection diagnostic tools, has obtained $57 million in an initial public ...Learn More
Leica strikes companion Dx development deal with Bristol
Leica Biosystems, a unit of Danaher, has agreed to develop fully automated companion diagnostic tests that can be used to ...Learn More
NanoString wins reimbursement coverage for breast cancer assay
Testing services that use NanoString Technologies' Prosigna Breast Cancer Gene Signature Assay will receive reimbursement ...Learn More
Former Baxano exec named sales VP of SpineFrontier
John Miller has been named vice president of sales at SpineFrontier, which specializes in spinal surgery implants and ...Learn More
Hologic gains license for DEXA imaging tool in Canada
Health Canada has granted a medical license to Hologic's Horizon technology, a dual-energy X-ray absorptiometry imaging ...Learn More
Aethlon prepares to launch U.S. studies of infection device
Aethlon Medical is gearing up for the first FDA-approved U.S. ...Learn More
Pilot trials underway for novel skin cancer imaging device
U.S. ...Learn More
FDA ban on 510(k) split predicates draws mixed reaction
Some industry stakeholders lauded the FDA's decision to prohibit the use of split predicates under the 510(k) program, ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Patience often gets the credit that belongs to fatigue.
Franklin Jones, American ...Learn More
SynCardia wins FDA nod for key component of artificial heart
SynCardia Systems' SynHall valves, the last component necessary for the production of the company's Total Artificial Heart, ...Learn More
Large medtech firms saw steady job gains in 2013, report finds
Twelve of the 15 biggest medical device manufacturers saw steady employment growth last year, according to an EP Vantage ...Learn More
Prenatal microarray tests boost Q2 revenues for CombiMatrix
CombiMatrix generated $1.9 million in revenues during the second quarter, up from $1.5 million during the same period last ...Learn More
Rex Bionics names former Smith & Nephew exec as new CEO
Crispin Simon, the former president of Smith & Nephew's endoscopy unit, has been tapped to serve as CEO of Rex Bionics, ...Learn More
Growth forecast for global orthopedic soft-tissue repair market
The global orthopedic soft-tissue repair market is poised for growth, driven by the aging population and the prevalence of ...Learn More
Podcast: Medtech legends and leaders on the state of medical device innovation
On July 15, MassDevice.com brought together CEOs from BiOM, Haemonetics, Insulet, Kips Bay Medical and MC10 to discuss the ...Learn More
REBIScan's device shows promise in pediatric vision loss study
REBIScan's device that uses polarized light to detect vision loss in pediatric patients showed promising results in a ...Learn More
DFINE's tumor ablation device shows positive trial results
A study in the Pain Physician journal showed that patients who received radio frequency ablation using DFINE's STAR Tumor ...Learn More
New blood imaging and analysis tool detects malaria
A mobile health tool has been designed to provide quick analysis of blood samples for the diagnosis of diseases such as ...Learn More
FDA sets review date for SonaCare's prostate cancer device
A panel of FDA advisers will convene on Oct. ...Learn More
St. Jude, Abbott score reimbursement wins for heart devices
St. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Failure is an event -- never a person.
William Brown, American ...Learn More
Hill-Rom's $250M purchase of Trumpf Medical finalized
Hill-Rom has wrapped up its purchase of German firm Trumpf Medical, along with its operating-room technologies, for $250 ...Learn More
Calif. molecular Dx firm obtains $12M in debt financing
SWK Funding has granted Response Genetics a credit facility worth as much as $12 million. ...Learn More
Bone suppression tool boosts revenue growth for Riverain
Revenues posted by Riverain Technologies in the first half of this year rose 34% compared with the same period last year. ...Learn More
DuoFertility to upgrade fertility monitor with $4M in fresh capital
A funding round has brought in $4.38 million for Cambridge Temperature Concepts, which has developed the DuoFertility system ...Learn More
New Zealand amends definitions for medical devices, drugs
Medsafe, New Zealand's drug and medtech regulator, has implemented its revised definitions for pharmaceutical and medical ...Learn More
CRO taps Ventana to provide companion Dx services in China
Ventana Medical Systems, a Roche unit, has struck a distribution deal with Quintiles, a contract research organization. ...Learn More
Study shows promising results for Bacterin's bone allograft
A study in the Journal of Foot & Ankle Surgery showed that trial participants saw substantial disability and pain ...Learn More
App to detect anemia nabs top prize at Microsoft tech challenge
A mobile health application that can be used to detect anemia in patients has nabbed the top prize at the 2014 Microsoft ...Learn More
2 patents issued to Baxano Surgical in U.S.
The number of U.S. ...Learn More
GE Healthcare seeks regulatory clearance for new PET/MR device
GE Healthcare is seeking FDA 510(k) clearance for its new Signa PET/MR scanner, which combines 3-Tesla MR technology with ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
You can't build a reputation on what you are going to do.
Henry Ford, American ...Learn More
Tecomet to pay $450M for Symmetry's orthopedic component unit
Tecomet has agreed to pay Symmetry Medical $450 million to acquire its OEM Solutions unit, which supplies instruments, ...Learn More
Eye surgery device firm closes $8M funding round
LensAR, which has developed an eye surgery device that uses lasers to treat presbyopia, has completed its $8 million ...Learn More
OHMK Medical buys 37.21% stake in EndyMed
OHMK Medical Technology has acquired a 37.21% stake in EndyMed, a maker of radio frequency-based medical devices, for $7 ...Learn More
Lubrizol expands health care footprint with Vesta buy
Lubrizol has strengthened its foothold in the health care space with its acquisition of Vesta Funding. ...Learn More
Medtronic launches hemodialysis facility in China
Medtronic has announced the launch of its facility in China that will house most of the firm's hemodialysis device ...Learn More
EU approves Transluminal Technologies' vascular closure system
European regulators have given Transluminal Technologies the CE mark for a device designed to seal arteriotomies in patients ...Learn More
Luminex's technology aids in Ebola Dx test development
Luminex reports that its xMAP technology is being used by the U.S. ...Learn More
DTRAX technology used in cervical spinal procedure in Wash.
A doctor at EvergreenHealth in Washington state has performed a procedure to stabilize the posterior cervical spine using ...Learn More
Carestream equips DR room with movement feature
Carestream Health has incorporated a Motor Assist capability into its DRX-Evolution digital radiography room. ...Learn More
ElMindA gains FDA clearance for brain analysis tool
The FDA has cleared ElMindA to market its device designed to assess brain activity in a noninvasive manner using signal ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Being defeated is often a temporary condition. Giving up is what makes it permanent.
Marilyn vos Savant, American ...Learn More
Cohera gains FDA panel support for surgical adhesive
A panel of FDA advisers has agreed to endorse approval for Cohera Medical's TissuGlu surgical adhesive, saying the ...Learn More
Catalent raises $871M from IPO; Lantheus delays IPO plans
Catalent, which develops drug delivery technologies, has obtained $871 million in an initial public offering. ...Learn More
Ohio surgical device firm advances funding round aiming for $10M
Ohio-based Checkpoint Surgical has secured nearly $7.5 million of a hoped-for $10 million financing round. ...Learn More
Stock offering planned by bone graft material company
Bacterin plans to sell common shares and apply part of the net proceeds to support general corporate functions. ...Learn More
Enforcement of new device, drug rules in Japan set for November
Regulators in Japan plan to implement its amended law governing medical devices and drugs marketed in that country on Nov. ...Learn More
Wyoming medical center buys electrolarynx devices for ICU
Wyoming's Cheyenne Regional Medical Center used grant money to purchase three electrolarynx devices for its ICU. ...Learn More
Sinus device with electromagnetic navigation unveiled by Medtronic
The NuVent EM Sinus Dilation System, which uses electromagnetic navigation to enable precise balloon placements, has been ...Learn More
EU trial begins for Implandata's wireless eye implant
Implandata Ophthalmic Products said it has initiated a clinical study in Europe to test the use of its Pro-IOP system in ...Learn More
FDA guidance would allow certain devices to skip 510(k) process
Draft guidance released by the FDA would allow certain devices to be released in the market without undergoing the 510(k) ...Learn More
Medicrea wins FDA nod for cervical fixation device
The FDA has granted Medicrea approval for its K-Jaws technology to be used for cervical fixation procedures involving ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Censorship reflects a society's lack of confidence in itself.
Potter Stewart, U.S. Supreme Court ...Learn More
FDA plans to subject lab-developed tests to regulatory oversight
The FDA has issued a guidance document detailing the agency's plans to regulate tests developed by laboratories. ...Learn More
For more:
Read a statement from AdvaMed commending the FDA's issuance of a draft framework for laboratory-developed test ...Learn More
3D Systems to pay $120M for surgical simulation tech firm
3D Systems has agreed to pay $120 million to acquire Simbionix, which develops 3D virtual reality tools for surgical ...Learn More
Cura to enter ultrasound market with DE Healthcare buy
Cura Healthcare, an India-based medical device company, has struck a deal to acquire DE Healthcare, a diagnostic imaging ...Learn More
Japan OKs monitor/defibrillator combo from Zoll Medical
Japanese regulators have granted Zoll Medical the green light to market its R Series system, which combines an automated ...Learn More
2 brain monitors from Vittamed gain approval in Europe
Regulators in Europe have given Vittamed the CE mark for a pair of devices that use ultrasound technology to monitor the ...Learn More
Report: Worldwide surgical device market poised for growth
A report from Allied Market Research forecasts that by 2020, the worldwide market for surgical equipment could be worth ...Learn More
Rotation Medical announces first use of its rotator cuff in U.S.
Rotation Medical's Rotator Cuff System will be used for the first time in the U.S. ...Learn More
J&J unit unveils guiding catheters for neurovascular procedures
Two guiding catheters tailored for use during neurovascular surgery are being launched by Codman Neuro, a unit of Johnson & ...Learn More
FDA's OK for Abiomed heart pump may come 2 months sooner
Abiomed said the FDA could reach a decision on its premarket approval application for the Impella device by March, two ...Learn More
Mauna Kea's advanced endomicroscopy technology gets FDA OK
The FDA has cleared Mauna Kea Technologies to market an advanced version of its Cellvizio endomicroscopy device. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
No one wants advice -- only corroboration.
John Steinbeck, American ...Learn More
FDA proposes device user fee reductions for FY 2015
The FDA's device center has issued a proposal to lower the medical device user fees for fiscal year 2015 by 3% across the ...Learn More
Report: X-ray market in U.S. could be worth $1.1B in 6 years
A GlobalData report forecasts that the U.S. ...Learn More
Blood pressure assets of Centron purchased by SunTech Medical
Blood pressure management firm SunTech Medical has agreed to pay an undisclosed sum to acquire the assets of Centron ...Learn More
Epic Sciences to advance cancer test with $30M in fresh capital
Epic Sciences has obtained $30 million in Series C financing, which CEO Murali Prahalad said will be used to bring the ...Learn More
EU adopts hazardous material restrictions for medical devices
The European Commission has adopted new rules mandating that all medical devices, except active implants, satisfy the ...Learn More
Report forecasts growth for global trauma fixation device market
A Transparency Market Research report predicts that the worldwide market for orthopedic trauma fixation systems could be ...Learn More
Calhoun Vision tackles the "Holy Grail" of ophthalmology with new lens
For years, the "Holy Grail" of ophthalmology has been to give patients the ability to see clearly in both near and far ...Learn More
Invitae enters genetic cancer test partnership with Nanopharmacia
Invitae will make its genetic assays for hereditary cancers available in Mexico under a deal reached with Nanopharmacia. ...Learn More
Glide Pharma gains rights to FScan's prostate cancer Dx technology
Glide Pharmaceutical Technologies was granted exclusive licensing rights to a prostate cancer diagnostic technology ...Learn More
Technology allows accurate detection of secondary cataracts
Spanish researchers have created a fully automatic tool that they say can detect posterior capsule opacity, or secondary ...Learn More
Proposed Mass. tax credit would offset 2.3% device tax
The fiscal 2015 budget approved by Massachusetts Gov. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Against the assault of laughter nothing can stand.
Mark Twain, American ...Learn More
Final rule prohibits "split predicates" under 510(k) process
The FDA has released a final rule disallowing use of "split predicates" under the agency's 510(k) clearance program. ...Learn More
Investors pump $172M into smart pill tech developer
Proteus Digital Health, which has developed a smart pill system with embedded sensors that link to a skin patch, has secured ...Learn More
Maker of smartphone-based vision testing device obtains $4M
A Series A funding round has pulled in $4 million for EyeNetra, the maker of a smartphone-based device that can be used to ...Learn More
Sequenom signs licensing deal with Mayo, posts Q2 revenue growth
Sequenom has agreed to license patents and applications related to its noninvasive prenatal tests to Mayo Medical ...Learn More
Medtronic strikes pacemaker manufacturing deal in China
Lifetech Scientific will work with Medtronic to manufacture pacemakers under an expanded deal reached between the companies. ...Learn More
AstraZeneca signs companion diagnostic deals with Roche, Qiagen
AstraZeneca has tapped Roche Holding and Qiagen to develop separate blood-based tests that can be used as companion ...Learn More
New device uses microscopic laser beams to draw blood
Scientists at NoNeedles Venipuncture are developing a new process that uses laser pulses instead of a needle to draw blood. ...Learn More
Intellijoint gains FDA OK for smart tool used during hip surgery
The FDA has cleared Intellijoint Surgical to market a smart tool designed to aid surgeons when performing hip replacement ...Learn More
Gonorrhea, chlamydia tests from Becton Dickinson win FDA nod
BD Diagnostics has received FDA clearance for a pair of tests used to detect gonococcal urogenital disease and chlamydia in ...Learn More
FDA OK for lung infection device sought by Asthma & Allergy
Asthma & Allergy Prevention Co. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
To invent, you need a good imagination and a pile of junk.
Thomas Edison, American ...Learn More
Medtech firms paid $1.4B in excise taxes in 2013, IRS data show
Data from the Internal Revenue Service indicate that medtech firms made excise tax payments of $1.4 billion last year when ...Learn More
Medtronic to pay up to $105M for laser ablation device firm
Medtronic has agreed to acquire Visualase, the maker of an MRI-guided laser ablation system used during minimally invasive ...Learn More
T2 Biosystems amends IPO target to as much as $65.9M
An initial public offering earlier announced by T2 Biosystems could bring in as much as $65.9 million in net proceeds, ...Learn More
Augmenix hopes to advance surgical hydrogel with $10.8M in financing
Augmenix has raised $10.8 million in Series D financing, which the Massachusetts-based company aims to use to support its ...Learn More
HealthTrust signs molecular Dx supply deal with BioFire
HealthTrust has tapped BioFire Diagnostics to supply its provider network with the company's multitarget molecular ...Learn More
Outgoing CFO of Covidien named to Haemonetics board
Charles Dockendorff has been appointed to serve on the board of directors at Haemonetics. ...Learn More
New GMP rules for medical devices proposed in S. Korea
The Ministry of Food and Drug Safety in South Korea has issued a proposal amending its good manufacturing practice rules for ...Learn More
Mainstay gets green light to expand ReActiv8 trial in U.K.
U.K. regulators have given Mainstay Medical the go-ahead to add U.K. ...Learn More
Advanced cervical-disk implant from Medtronic wins FDA nod
Medtronic has won FDA approval to market an updated version of its Prestige cervical-disk implant launched in 2007. ...Learn More
Quidel's Group A strep test lands FDA clearance
Quidel has received clearance from the FDA to market its AmpliVue GAS Assay. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
We must open the doors of opportunity. But we must also equip our people to walk through those doors.
Lyndon B. Johnson, 36th U.S. ...Learn More
Sorin's next-gen heart valve wins approval in Europe
Sorin has earned the CE mark in Europe for its Crown PRT, a next-generation device used to treat patients with aortic valve ...Learn More
Cardiovascular molecular Dx firm advances $25M funding round
A regulatory filing disclosed that CardioDx has obtained $21 million in a funding round aiming for $25 million. ...Learn More
Funding round brings in $6M for CyMedica Orthopedics
CyMedica Orthopedics has pulled in $6 million in a financing round, according to a regulatory filing. ...Learn More
Minn. surgical-waste-management firm obtains funds
Skyline Medical, which specializes in surgical-waste management, has received from two undisclosed backers more than ...Learn More
Surgical-implant business helps boost Q2 sales for DJO Global
DJO Global posted $313.9 million in net sales during the second quarter, a 6.5% increase over the same period in 2013. ...Learn More
Canadian hospital gets $1.4M boost to build molecular oncology lab
The Ottawa Hospital is set to establish a molecular oncology diagnostic facility using $1.4 million in financing. ...Learn More
Ohio hospital first to use Aurora's bone allograft in U.S.
A doctor at Madison County Hospital in Ohio has performed the first U.S. ...Learn More
Qiagen gains license for potential blood cancer biomarkers
Qiagen has licensed four biomarkers from the University of Tokyo that can be used for assessing treatment prognosis in blood ...Learn More
MIT-developed test offers cheaper, easier way to detect cancer
A professor at the Massachusetts Institute of Technology has created an assay that can be used to detect cancer with the ...Learn More
Medtronic agrees to pay $2.8M to settle insulin pump lawsuit
Medtronic has reached a $2.8 million settlement deal with the federal government and 36 states to resolve a lawsuit accusing ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
There is no disguise which can hide love for long where it exists, or simulate it where it does not.
Francois de La Rochefoucauld, French ...Learn More
Boston Scientific's drug-coated balloon wins EU approval
Regulators in Europe have granted the CE mark to Boston Scientific's Agent balloon catheter, designed to treat patients with ...Learn More
Pa. cardiovascular device firm lands $3.85M investment
Pennsylvania-based Intelomed, the maker of a noninvasive tool for real-time detection of a patient's risk for cardiovascular ...Learn More
3 medtech startups receive $100K each in Md. innovation awards
Three startups developing medical technologies won investments worth $100,000 each from the Maryland Innovation Initiative. ...Learn More
Illumigene products help fuel FY Q3 sales growth for Meridian
Meridian Bioscience generated $47.2 million in sales during the company's fiscal year 2014 third quarter, up from $47.1 ...Learn More
Millstone Medical to expand facility, workforce in Mass.
Millstone Medical Outsourcing has announced plans to add 40,000 square feet to its existing medical-device packaging and ...Learn More
Elekta hopes to expand footprint in Turkey with Mesi Medikal buy
Elekta has agreed to acquire Mesi Medikal, a distributor of radiation therapy devices in Turkey, for undisclosed terms. ...Learn More
Grifols gets CE mark for hepatitis E detection test
Grifols has earned the CE mark in Europe for the Procleix HEV test, which it developed with Hologic. ...Learn More
Study of staph infections on implanted devices wins $10M grant
A University of Nebraska Medical Center study of antibiotic-resistant infections related to implanted devices has won a $10 ...Learn More
Philips' mobile ultrasound scanner scores FDA clearance
The FDA has cleared Philips Healthcare to market its Visiq system, a mobile ultrasound scanner designed to ease the way ...Learn More
FDA OKs Spectranetics' devices to treat in-stent restenosis
Spectranetics has received 510(k) clearance from the FDA for its Turbo Elite and Turbo-Tandem peripheral atherectomy ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The important thing in life is not to have a good hand but to play it well.
Louis Fortin, ...Learn More
Teleflex's chronic hemodialysis catheter wins FDA nod
The FDA has cleared Teleflex to market its Arrow-Clark VectorFlow catheter, designed for use in patients undergoing chronic ...Learn More
Infectious-disease-product sales boost Q2 revenue for Quidel
Quidel posted $31.5 million in revenue during the second quarter, up from $29.7 million during the same period last year. ...Learn More
Connecticut Innovations awards $10K each to 2 medtech startups
Vesselon and 109 Design were among five startups in Connecticut that won $10,000 each through Connecticut Innovations' ...Learn More
ConMed picks former Stryker exec to serve as interim CEO
Former Stryker Chief Financial Officer and interim CEO Curt Hartman has been tapped to serve as interim CEO of ConMed. ...Learn More
New medtech classification system proposed in Russia
Regulators in Russia have proposed a new system to classify medical devices in that country based on the Global Medical ...Learn More
IMRIS' surgical theater with advanced MRI feature gains CE mark
IMRIS has won CE mark approval in Europe to market its Visius Surgical Theatre, which features a next-generation version of ...Learn More
Podcast: CEO Brian Concannon on the past and future for Haemonetics
Haemonetics CEO Brian Concannon discusses how the company will transform blood management in the coming years at ...Learn More
NeuroPace partners with DARPA on memory-loss study
The Defense Advanced Research Projects Agency has tapped NeuroPace to investigate the use of implantable neurostimulators to ...Learn More
Lung cancer study to use Foundation Medicine's assay
The Bonnie J. ...Learn More
Breast density software from VuCOMP cleared in Canada
VuCOMP has received the green light to market its M-Vu Breast Density technology in Canada. ...Learn More
Proposed Sunshine regulations could mean new costs for medtech firms
Experts have voiced concerns that proposed changes to the Physician Payments Sunshine Act, which requires health care firms ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Progress begins with the belief that what is necessary is possible.
Norman Cousins, American ...Learn More
St. Jude earns CE mark for next-gen heart ablation device
St. ...Learn More
J&J's $5B share repurchase program wins board approval
A plan by Johnson & Johnson to buy back as much as $5 billion of its stock has been approved by the company's board. ...Learn More
First tranche of Trice Medical's $11.6M funding round completed
Trice Medical has completed the first part of its Series B funding round aiming for $11.6 million. ...Learn More
Mass. miRNA assay firm advances $1.5M funding round
A funding round aiming for $1.5 million has brought in $775,000 for Firefly BioWorks. ...Learn More
Hanson tapped to serve as group president at Covidien
Bryan Hanson, president of Covidien's medical device unit, has been appointed to serve as the company's group president. ...Learn More
Comments sought on EU proposal to evaluate nano-based devices
The European Commission has released preliminary guidelines governing the risk assessment of medical devices that use ...Learn More
Company developing point-of-care Dx test gets $2.5M boost
SenGenix, a Duke University spinoff, has received $2.5 million from investors. ...Learn More
N.Y. grants final approval for Rosetta's kidney cancer test
The Department of Health in New York state has given Rosetta Genomics final approval to offer its kidney cancer test in the ...Learn More
Advanced intravascular ultrasound introduced by Boston Scientific
Boston Scientific has expanded its intravascular ultrasound product line with the release of its Polaris system. ...Learn More
FDA gives green light to Veniti's venous stent trial
The FDA has granted Veniti investigational device exemption to conduct a clinical study of its Vici Venous Stent System, ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
The young do not know enough to be prudent and therefore they attempt the impossible -- and achieve it, generation after generation.
Pearl S. Buck, American ...Learn More
Boston Scientific gets FDA green light for bare-metal stent
The FDA has granted Boston Scientific approval to market a bare-metal stent built out of the same architecture and platinum ...Learn More
Illumina receives $1.5M in tax breaks in San Diego
San Diego has agreed to provide Illumina with tax incentives worth $1.5 million over a period of 10 years, keeping the ...Learn More
Firms jointly develop next-generation sequencing tech
Illumina and Berry Genomics have created a next-generation sequencing tool that combines Berry's Bambni noninvasive prenatal ...Learn More
Pain management device firm gets new CFO
Brian Alleman has been appointed to replace Anthony Scalese as chief financial officer of Zynex, a maker of noninvasive ...Learn More
New U.K. committee aims to improve access to medtech specialist advice
The U.K. ...Learn More
Companies in Italy must register certain IVD medical devices in national database
New rules require IVD companies operating in Italy to register their products in the Repertorio national database of medical ...Learn More
Study of Medrobotics' surgical robot kicks off in Germany
Doctors at a hospital in Germany were the first to use Medrobotics' Flex surgical robot to successfully remove cancerous ...Learn More
ConforMIS' device fares better than standard implants in TKA study
A clinical study found that patients treated with the ConforMIS iTotal personalized knee implant had lower hospital costs, ...Learn More
Soft-tissue transponder from Varian Medical wins FDA nod
Varian Medical Systems has been cleared by the FDA to market its Calypso Beacon transponder, which the company said can be ...Learn More
Sunshine Act disclosure website marred by glitches, reports say
Early reports show some glitches with the Open Payments website, the federal database designed to show doctor payments from ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Too often we enjoy the comfort of opinion without the discomfort of thought.
John F. Kennedy, 35th U.S. ...Learn More
Cost of disease is countered by medtech benefits, study finds
The benefits of medical technology contribute a net added benefit of $23 billion per year, according to a report published ...Learn More
For more:
Read the AdvaMed press release with President and CEO Stephen Ubl's comments commending the findings of the Milken Institute ...Learn More
Bausch + Lomb gains FDA OK for cataract surgery device
The FDA has given Bausch + Lomb 510(k) clearance to market its VICTUS femtosecond laser system. ...Learn More
Thermo Fisher agrees to $480M sale of laboratory unit
Thermo Fisher Scientific has struck a deal to sell its Cole-Parmer laboratory equipment business to GTCR, a private equity ...Learn More
Arup Laboratories to distribute HIV test across U.S.
Arup Laboratories has agreed to market nationwide an HIV assay developed at University Hospitals Case Medical Center. ...Learn More
Rules governing medtech studies, registrations issued in India
Regulators in India have released guidelines explaining the requirements for registering medical devices and conducting ...Learn More
Mazor's surgical robot shows efficacy in scoliosis trial
A clinical study found that surgeons who used Mazor Robotics' Renaissance system positioned pedicle screws in adolescent ...Learn More
N.Y. approves institute's cancer molecular Dx test
The Department of Health in New York state has authorized the Roswell Park Cancer Institute to use OmniSeq Target assay in ...Learn More
Next-gen bone graft from Synergy gets wider FDA OK
Synergy Biomedical has been cleared by the FDA to expand the use of its BioSphere Putty, a next-generation bone graft that ...Learn More
FDA creates educational program to spur medtech development
The FDA has developed a program to educate students and entrepreneurs about the agency's process for evaluating medical ...Learn More
FDA expands clearance for Blue Belt's surgical device
The FDA has granted Blue Belt Technologies expanded clearance for its Navio surgical system to be used during patellofemoral ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
I give myself sometimes admirable advice, but I am incapable of taking it.
Mary Wortley Montagu, British ...Learn More
Danaher unit to acquire Siemens' clinical microbiology division
Beckman Coulter, a unit of Danaher, has agreed to pay an undisclosed sum to acquire the clinical microbiology business of ...Learn More
Lantheus' planned IPO could bring in up to $139M
Massachusetts-based Lantheus Medical Imaging said it could pull in up to $139 million from its planned initial public ...Learn More
N.J. molecular Dx firm eyes $60M from IPO
New Jersey-based Roka Bioscience looks to obtain $60 million in an initial public offering. ...Learn More
Clinical molecular biology sales boost revenue growth for bioMerieux
BioMerieux posted net sales of $1.06 billion during the first half of this year, up almost 4% from the same period last ...Learn More
EU grants CE mark for Biotronik's MRI-safe defibrillators
Biotronik has earned the CE mark in Europe for its Inventra line of implantable cardiac resynchronization therapy ...Learn More
Report: Global surgical navigation tech market poised for growth
A report from Transparency Market Research predicts that the worldwide market for surgical navigation tools could increase ...Learn More
Foundation awards $4.7M for prostate cancer test development
The Movember Foundation has awarded $4.7 million to a team of Canadian scientists to support the development of molecular ...Learn More
Longitudinal Prize offers $17.1M for point-of-care bacterial infection test
The Nesta Foundation, the Technology Strategy Board of the U.K. and the British Broadcasting Corp. ...Learn More
Knee arthroplasty technology unveiled by Exactech
The Optetrak Logic Porous technology, which features an advanced implant coating, has been introduced by Exactech. ...Learn More
Obama administration urged to block FDA's plan to regulate LDTs
A group of laboratory directors has called on the Obama administration to prevent the FDA from regulating ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Most of us spend too much time on what is urgent and not enough time on what is important.
Stephen Covey, American writer and ...Learn More
SynCardia gains FDA OK for portable artificial heart driver
The FDA has granted SynCardia Systems approval to market the Freedom driver for use with the company's Total Artificial ...Learn More
Group looks to invest up to $60M in life sciences startups
A fund worth as much as $60 million is being raised by the New York City Economic Development Corp. ...Learn More
Illumina buys companion Dx consulting firm
Illumina has agreed to pay an undisclosed sum to purchase Myraqa, which provides regulatory and quality consulting services ...Learn More
Medbio breaks ground on $3.39M facility expansion in Mich.
Medbio has initiated a project to expand its production and warehouse facility in Cascade Township, Mich. ...Learn More
Report: Global medical polymer market could hit $7.05B by 2020
The growing use of high performance polymers to replace metal and glass in medical devices could help the worldwide medical ...Learn More
Podcast: Medical device execs discuss M&A activity
MassDevice.com speaks to 3M's Deb Rectenwald, St. ...Learn More
BioTheranostics gets OK to distribute breast cancer Dx in N.Y.
BioTheranostics has received the go-ahead to distribute its Breast Cancer Index in New York. ...Learn More
Covidien's soft tissue ablation device could hit market in Q3
Covidien said its Emprint system, which was cleared by the FDA in April, could be available commercially in the third ...Learn More
Cartilage allograft kit from RTI debuts at conference
A device used for osteochondral allograft resurfacing was introduced by RTI Surgical at a recent sports medicine conference ...Learn More
DorsaVi's activity-monitoring device lands FDA clearance
The FDA has cleared dorsaVi to market its ViMove system for use in clinical settings or athletic training. ...Learn More
FDA clears IBA's compact gantry for proton therapy device
Ion Beam Applications has been cleared by the FDA to market its Compact Gantry Beam Line, which will be integrated with the ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Be brave enough to start a conversation that matters.
Margaret Wheatley, American ...Learn More
Boston Scientific's 25 mm heart valve clears EU hurdle
European regulators have granted Boston Scientific CE mark approval to sell a 25-millimeter model of its Lotus transcatheter ...Learn More
Mass. startup behind vascular sleeve tech gets $11M boost
A round of financing from six undisclosed backers has pulled in $11 million for Massachusetts-based Neograft. ...Learn More
Calif. glucose device company advances $5.1M funding round
Metronom Health has secured $4.8 million in a financing round aiming for $5.1 million. ...Learn More
N.Y. grants conditional OK for CombiMatrix's pediatric disorder test
The New York State Department of Health has given CombiMatrix conditional approval to distribute its CombiSNP test for ...Learn More
Transplant Genomics secures license to patents related to transplant diagnostics
Transplant Genomics has gained an exclusive license to patent rights on technology from The Scripps Research Institute and ...Learn More
Mexico approves Guided Therapeutics' cervical scanning device
Guided Therapeutics has received the go-ahead in Mexico to market its LuViva Advanced Cervical Scan, a noninvasive scanning ...Learn More
Canadian molecular Dx firm obtains $23.8M in Series B financing
Xagenic, whose flagship product is the Amplified Redox Assay that can quickly detect nucleic acids in clinical samples ...Learn More
Novartis, Google partner on contact lenses to track blood glucose levels
Novartis and Google are partnering on "smart" contact lenses that could track diabetics' blood glucose levels. ...Learn More
Device shows promise for early detection of Alzheimer's
A device being commercialized by NeuroVision Imaging has been shown in a 40-patient study to have the ability to accurately ...Learn More
FDA OKs Dallen's disposable small-bone fixation device
The FDA has cleared a disposable model of Dallen Medical's Compressyn Staple Delivery System. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
I never dreamed about success. I worked for it.
Estee Lauder, American ...Learn More
St. Jude strikes deal to acquire NeuroTherm for $200M
St. ...Learn More
N.C. cancer Dx firm secures $5M in financing
A regulatory filing disclosed that GeneCentric Diagnostics has obtained $5 million in a funding round. ...Learn More
Miacom signs pathogen Dx distribution deal with Fosun
China-based Fosun Diagnostics has agreed to distribute Miacom Diagnostics' proprietary multiplex tests in Asia. ...Learn More
Intact picks former Neuronetics exec as president and CEO
Intact Vascular has appointed Bruce Shook to serve as its new president and CEO, replacing Carol Burns. ...Learn More
Boston Scientific's drug-eluting balloon gets CE mark
Boston Scientific has received CE mark approval to market its Ranger device in Europe. ...Learn More
"Swimmable" hearing implant gains approval in China
Chinese regulators have granted Advanced Bionics the green light to market its Neptune cochlear implant for use by patients ...Learn More
C2N gains global commercial rights for Alzheimer's assay
The Washington University School of Medicine has granted C2N Diagnostics exclusive rights to market worldwide a clinical ...Learn More
Mitek launches platelet-rich-plasma device
Mitek Sports Medicine has released a lightweight device that can isolate platelet-rich-plasma from the patient's blood. ...Learn More
510(k) risk-benefit review proposal issued by FDA
Draft guidance released by the FDA outlines how the agency evaluates the risks and benefits of medical devices submitted ...Learn More
Lateral fusion device from Titan Spine receives FDA OK
Titan Spine's Endoskeleton TL device, designed for lateral spinal fusion surgery, has been cleared by the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
No person was ever honored for what he received. Honor has been the reward for what he gave.
Calvin Coolidge, 30th U.S. ...Learn More
Eye device firm targets as much as $80M from IPO
Massachusetts-based Ocular Therapeutix said it will launch an initial public offering in hopes of obtaining up to $80 ...Learn More
N.Y. cancer Dx firm receives $1M funding boost
Empire Genomics, which specializes in cancer diagnostics, has raised $1 million in a recent funding round. ...Learn More
Integra increases credit facility to $900M
Integra LifeSciences has raised its credit facility to $900 million, which will be due July 2, 2019. ...Learn More
Former Medtronic exec to take the helm of CryoLife
James Patrick Mackin, a former executive at Medtronic, has been appointed to serve as president and CEO of CryoLife ...Learn More
Aging population predicted to drive global ultrasound market growth
A Transparency Market Research report projects that the worldwide ultrasound device market could be valued at $8.7 billion ...Learn More
EU grants CE mark for Natera's cloud-based tool
Natera has won CE mark approval to market its cloud-based technology in Europe. ...Learn More
Study shows promising results for Abbott's MitraClip device
A clinical study found that 84% of patients saw reduced mitral regurgitation, improved quality of life and decreased ...Learn More
Quantel Medical lands FDA clearance for Optimis Fusion platform
Quantel Medical garnered FDA approval for its Optimis Fusion ophthalmic laser platform for the treatment of cataracts and ...Learn More
List of recognized medtech standards updated by FDA
The FDA has updated its list of recognized standards for premarket evaluation of medical devices to include 33 new entries, ...Learn More
FDA authorizes Qubyx to sell imaging tech package
The FDA has cleared Qubyx to market the Dell UltraSharp U3014 display in combination with the Qubyx PerfectLum DICOM ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
There's a great power in words, if you don't hitch too many of them together.
Josh Billings, American ...Learn More
VCs backed $2.7B in health care deals in Q2
Venture capitalists invested about $2.7 billion in 161 health care deals in the second quarter, according to CB Insights' ...Learn More
ReShape raises $4M to pursue FDA OK for obesity device
A regulatory filing disclosed that ReShape Medical has secured $4 million in a debt funding round. ...Learn More
Calif. cryoablation-device firm advances $12M financing round
A Series B funding round aiming for $12 million has pulled in $500,000 for CryoMedix. ...Learn More
PPO awards cancer Dx contract to bioTheranostics
FedMed, a Maryland-based preferred provider organization, has awarded a contract to bioTheranostics. ...Learn More
EU OKs interbody fusion device from Expanding Orthopedics
Expanding Orthopedics has earned the CE mark in Europe for its FLXfit system, a 3D expandable cage used during minimally ...Learn More
Ventana, Merck sign companion Dx development deal
Merck KGaA has tapped Ventana Medical Systems to create and validate a companion diagnostic assay that will be used for ...Learn More
Konica to equip scanner with ultrasound training package
Konica Minolta Medical Imaging said it will integrate its Sonimage P3 handheld scanner with SonoSim's ultrasound training ...Learn More
Microarray test designed to ID cause of multiple miscarriages
A microarray test meant to help identify the exact reason for multiple miscarriages has been developed by CombiMatrix. ...Learn More
FDA allows Cook Medical's Evolution devices to re-enter market
The FDA has permitted Cook Medical to resume U.S. ...Learn More
Medicare coverage for melanoma device sought by Mela Sciences
Mela Sciences has submitted documents to earn a Medicare Part B reimbursement code for its MelaFind system, a handheld ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
If once you forfeit the confidence of your fellow citizens, you can never regain their respect and esteem.
Abraham Lincoln, 16th U.S. ...Learn More
Merit unit gains OK for tracheobronchial stent in China
Merit Medical subsidiary Endotek has received the green light to market its Aero tracheobronchial stent, along with the ...Learn More
Calif. heart failure device firm gets $12.4M boost
California-based BioVentrix has raised $12.4 million in a round of financing from 195 undisclosed backers. ...Learn More
Cardiac Insight obtains $7M in funding round
A funding round has pulled in $7 million for Cardiac Insight, a spinoff of the University of Washington. ...Learn More
Maker of uterine fibroid device gains $6.3M in fresh capital
A group of 16 undisclosed backers has pumped $6.3 million into Gynesonics, the maker of the VizAblate system that combines ...Learn More
NeoGenomics pays $6M for pathology services firm
NeoGenomics, which specializes in cancer genetic tests, has agreed to pay $6 million to purchase Path Labs, which it will ...Learn More
ViaLogy reverse takeover leads Premaitha to gain AIM listing
Premaitha Health's reverse takeover of ViaLogy has allowed the U.K.-based prenatal test firm to trade stocks on the AIM ...Learn More
EU approves CorTechs Labs' brain imaging tool
Regulators in Europe have given CorTechs Labs CE mark approval for its NeuroQuant software, a volumetric brain imaging tool ...Learn More
Silicon Valley in-depth: Unraveling arrhythmia with iRhythm CEO Kevin King
Kevin King, CEO of Silicon Valley digital health company iRhythm, tells MassDevice about the promise of Big Data and how ...Learn More
DARPA awards $40M for development of brain implant
The University of Pennsylvania, the Lawrence Livermore National Laboratory and the University of California, Los Angeles, ...Learn More
British study shows promise of blood test to predict Alzheimer's
A blood test that identifies a set of 10 proteins can predict the onset of Alzheimer's disease within a year with 87% ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
When it comes to human dignity, we cannot make compromises.
Angela Merkel, German ...Learn More
FDA OKs NeuroMetrix's chronic pain device for nonprescription use
The FDA has cleared NeuroMetrix to market a wearable device designed to treat chronic pain without the need for a ...Learn More
Airway mapping device firm advances $7.5M funding round
A group of 18 undisclosed backers has pumped $6.5 million into Veran Medical Technologies, bringing the company closer to ...Learn More
Mariel buys Stryker's bone morphogenetic protein-7 assets
Mariel Therapeutics has agreed to acquire the bone morphogenetic protein-7 assets of Stryker for undisclosed terms. ...Learn More
Biomatrica licenses reagent technology to Microbiologics
Biomatrica has granted Microbiologics licensing rights for its RNAstable and DNAstable reagents used to stabilize RNA and ...Learn More
Former Acclarent exec named COO of Benvenue Medical
Jeffrey Jones has been tapped to serve as chief operating officer of Benvenue Medical. ...Learn More
Magnetodyn to sell patented bone, tissue regeneration tech
Magnetodyn has struck a deal to sell patents related to its bone and tissue regeneration technology to German firm Munich ...Learn More
Swiss bioinformatics firm obtains $13.75M in Series B financing
A Series B round of financing has pulled in $13.75 million for Sophia Genetics. ...Learn More
Startup behind pill-scanning device gets funding boost
Mint Solutions has raised $6 million in a round of Series A financing headed by Seventure Partners and Life Sciences ...Learn More
Nortis eyes 2015 release of organ-mimicking microfluidic chip
Nortis has obtained $2 million in financing, which CEO Thomas Neumann said will be used to help bring the company's ...Learn More
Uterine fibroid devices to undergo FDA scrutiny
An FDA panel of advisers will convene on Thursday and Friday to explore possible changes to the labeling, instructions for ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Failure is simply the opportunity to begin again, this time more intelligently.
Henry Ford, American ...Learn More
FDA lowers regulatory bar for headache devices
The FDA has lowered the risk classification of noninvasive systems to treat headache from Class III to Class II devices with ...Learn More
N.J. maker of insulin delivery device obtains about $22M
Valeritas has secured approximately $22 million in a funding round that the company hopes will bring in up to $45 million. ...Learn More
Natera enters genetic-test partnership with Mount Sinai
The Mount Sinai Genetic Testing Laboratory has agreed to provide Natera's Horizon test used for genetic-carrier screening. ...Learn More
Former AtriCure CEO takes the helm of JenaValve
David Drachman has been appointed to serve as the new CEO of JenaValve, the maker of a transcatheter aortic valve implant ...Learn More
ArcticDx signs deal to bring its AMD test to Canada
ArcticDx has granted AMD Insight exclusive licensing rights for its Macula Risk PGx assay, designed to assess a patient's ...Learn More
Firms ally to develop tests to customize statin drugs
A deal struck between Genomas and AutoGenomics aims to create genetic assays and DNA-based diagnostic tools that can be used ...Learn More
Advanced X-ray angiography system unveiled by Toshiba
An advanced X-ray angiography device, called Infinix Essential, has been introduced by Toshiba America Medical Systems. ...Learn More
Diazyme's iron deficiency test lands FDA clearance
The FDA has cleared Diazyme Laboratories, a General Atomics unit, to market its ferritin immunoturbidimetric assay for ...Learn More
CAS Medical reaches settlement deal with Covidien unit
CAS Medical said it has agreed to pay Covidien unit Nellcor $275,000 to settle a patent litigation with prejudice. ...Learn More
FDA input sought by Mainstay Medical for ReActiv8 system
A pre-investigational device exemption information package has been presented to the FDA by Mainstay Medical for the ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Let no one ever come to you without leaving better and happier.
Mother Teresa, Albanian-Indian nun and ...Learn More
Thoratec to acquire Apica Cardiovascular for up to $75M
Thoratec has agreed to acquire Apica Cardiovascular for $35 million in cash, plus as much as $40 million in milestone fees. ...Learn More
Shares offering could pull in $6.8M for GeneNews
Toronto-based GeneNews, which specializes in molecular diagnostic tests, seeks to obtain $6.8 million in a private shares ...Learn More
Veracyte's genomic test scores reimbursement win from 2 insurers
Veracyte's Afirma Gene Expression Classifier has been found by Horizon Blue Cross Blue Shield of New Jersey and Highmark to ...Learn More
Echo Therapeutics names interim CEO, looks for new CFO
Kimberly Burke has been tapped to serve as interim CEO of Echo Therapeutics until Aug. 30 or when a permanent CEO is hired. ...Learn More
NuVasive to build global operations center in Ireland
California-based NuVasive, which specializes in minimally invasive spinal surgery devices, is setting up an international ...Learn More
Strong growth forecast for Chinese X-ray imaging market
GlobalData predicts the Chinese market for X-ray imaging systems could be worth $1 billion by 2020, driven in part by the ...Learn More
Medtronic's device fares better than daily injections in diabetes trial
A clinical study of more than 330 participants in Canada found that type 2 diabetes patients using Medtronic's MiniMed ...Learn More
Vital-signs-monitoring chair from EarlySense gains FDA OK
The FDA has cleared EarlySense to market a sensor that can monitor a patient's heart rate, respiratory rate, movement and ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The important thing is not to stop questioning.
Albert Einstein, German-American theoretical ...Learn More
T2 Biosystems plans to go public to raise $69M
T2 Biosystems, which develops MRI-based infection diagnostic tools, hopes to raise up to $69 million in an initial public ...Learn More
Abiomed pays more than $30M for 2 German medtech firms
Abiomed has agreed to acquire Entwicklungsgessellschaft, a German firm developing a catheter-based heart pump, for $13 ...Learn More
Rotation Medical obtains $27.2M in Series B financing
A Series B funding round has brought in $27.2 million for Rotation Medical, the maker of a collagen scaffold designed to ...Learn More
Report: Worldwide companion Dx market poised for robust growth
A Research and Markets report forecasts that the worldwide companion diagnostics market, which reached $26 billion last ...Learn More
Podcast: Covidien's Enxing Seng talks Medtronic merger, future of medicine at DeviceTalks
Covidien's Stacy Enxing Seng speaks to MassDevice.com about the Medtronic merger during our DeviceTalks Minnesota ...Learn More
Research project aims to evaluate immune competence
The Singapore Immunology Network will work with French molecular diagnostics company ImmunID on a clinical study evaluating ...Learn More
Thermedx's fluid-warming technology wins expanded FDA OK
The FDA has given Thermedx expanded clearance to market its fluid-warming system for use during hysteroscopic and ...Learn More
FDA's 4-year plan includes focus on safety and quality
The FDA has issued a draft document outlining a four-year plan that will focus on five key areas, including regulatory ...Learn More
St. Jude resolves manufacturing issues at Calif. plant
The FDA has issued a notice clearing St. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
SmartBrief will not publish Friday
In observance of Independence Day in the U.S., SmartBrief will not publish on Friday. Publication will resume ...Learn More
Beware; for I am fearless, and therefore powerful.
Mary Shelley, English ...Learn More


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In the News
Cutting-Edge Device Could Reverse Damage Caused by Heart Disease
By: James Walsh | November 2013

Sunshine Heart's C-Pulse device, which could reverse heart damage in some patients, has a potential worldwide market of up to $1 billion, an analyst says.

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New Medical Technologies Offer Hope for Sleep Apnea
By: Karen Weintraub | November 2013

Sleep apnea affects an estimated 5% to 10% of Americans and is undiagnosed in most of them. It can also lead to obesity, diabetes, high blood pressure, strokes and heart attacks. 

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Pacemaker May Help Arizona Boy Breathe Without a Ventilator
By: Angela Gonzales | November 2013

Phoenix Children's Hospital is conducting a new treatment because doctors listened to a patient’s mom.

 
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Despite Downturn in Pace of Startups, Med Tech Entrepreneurs Optimistic
By: Chris Arnold | October 2013

Since the financial crisis hit five years ago, there aren't as many Americans starting new businesses. In uncertain economic times, it's harder for entrepreneurs and investors to take the risk.  

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