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Investors pump $35M into Calif. genomic Dx firm
Redwood City, Calif.-based CardioDx has raised $35 million from a funding round that included Alberta Investment Management ...Learn More
Knee implant device startup raises over $7.8M in funding
Cotera, a startup developing knee implant devices for treating osteoarthritis, has secured over $7.8 million through an ...Learn More
Prices of drug-eluting stents dropped 6% in 2014, index shows
The Modern Healthcare/ECRI Institute Technology Price Index reported a 6% decrease in the average price paid by hospitals ...Learn More
Elekta wins clearance for brachytherapy system in China
Chinese regulators have granted Elekta, which develops radiation oncology systems, clearance to market its Flexitron ...Learn More
179-gene panel shows 78% success rate in detecting gene mutation
A study in PLOS ONE shows how effective a next-generation sequencing multiplex assay can be in analyzing and identifying ...Learn More
MolecularMD NGS lab accredited by CAP
The College of American Pathologists has accredited the next-generation sequencing laboratory operated by MolecularMD in ...Learn More
Paramed Medical announces new MROpen scanner applications
Paramed Medical Systems is set to expand its MROpen scanner clinical applications in 2015 by offering applications for ...Learn More
Updated home heart monitor from AliveCor set to launch in January
An upgraded version of AliveCor's home heart monitor is set to launch in January on Amazon.com and through a collaboration ...Learn More
Surgical sealant from Cohera wins FDA priority review status
The FDA has given priority review status to Cohera Medical's Sylys Surgical Sealant. ...Learn More
FDA clears Memo3d ReChord implant from Sorin Group
The Memo3d ReChord, a surgical implant developed by Sorin Group, has obtained 510(k) clearance from the FDA. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
Life is a blank canvas, and you need to throw all the paint on it you can.
Danny Kaye, American actor and ...Learn More
Royal Philips to acquire Volcano in $1.2B deal
Royal Philips announced Wednesday it will purchase Volcano and its cardiovascular imaging technology, including its debt, ...Learn More
Varian to purchase German firm MeVis in $37M-plus deal
Varian Medical Systems has agreed to purchase MeVis Medical Solutions for nearly $37.3 million in a deal that is anticipated ...Learn More
Orthopedic device developer secures $12M investment
Sonoma Orthopedic Products has obtained a $12 million boost from private growth-equity investor First Analysis. ...Learn More
FDA, HHS awards joint Dx development contract to Diatherix
Diatherix Laboratories has entered a one-year joint contract with the FDA and HHS. ...Learn More
Firm earns CE mark for PEEK-OPTIMA HA implant
Karmed Saglik Group has obtained the CE mark for its first implant developed using the PEEK-OPTIMA HA Enhanced implantable ...Learn More
DeviceTalks podcast: Masimo CEO Kiani talks patient safety, corporate culture and debunking the "innovators dilemma"
An interview with medtech entrepreneur Joe Kiani, CEO of Masimo Corp. ...Learn More
Trial set to evaluate VolitionRx's lung cancer assay
A clinical trial is set to get underway at the University of Bonn in Germany to evaluate VolitionRx's Nucleosomics platform, ...Learn More
Dutch study validates use of thrombectomy devices for treating stroke
Thrombectomy devices demonstrated positive results in a Dutch trial involving 500 acute ischemic stroke patients. ...Learn More
Integra to debut skin regeneration template for burns, scars
Integra LifeSciences is set to expand its skin repair product line in January with the introduction of its Meshed Dermal ...Learn More
FDA clears surgical system from THINK Surgical
The TSolution One Surgical System developed by THINK Surgical has obtained 510(k) clearance from the FDA. ...Learn More
Cerus' Intercept Blood System wins FDA approval
Cerus has received FDA approval for its Intercept Blood System. ...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 the steady, quiet, plodding ones who win in the lifelong race.
Robert Service, British-Canadian ...Learn More
Medtronic-Covidien deal wins all required anti-trust approvals
Medtronic announced that it has gained the necessary approvals from U.S., European Union, Canadian, Chinese and South Korean ...Learn More
Mass. gives $1M for development of hand-held Ebola Dx device
Diagnostics for All has been awarded a $1 million grant from the state of Massachusetts to help fund the development of a ...Learn More
CytoSorbents taps Fresenius Medical Care to offer product in Europe
CytoSorbents has secured a distribution deal with Fresenius Medical Care to help bring its CytoSorb blood purification ...Learn More
In vitro Dx company completes part of funding round
Protagen, a developer of in vitro diagnostic tests for diseases including systemic sclerosis and rheumatoid arthritis, has ...Learn More
U.K. oncology Dx firm to get $19.7M boost
Investment company Syncona Partners will pump $19.7 million in equity financing into U.K.-based 14M Genomics, a developer of ...Learn More
CVRx wins expanded EU approval for Barostim neo
CVRx has earned additional clearance from the European Union for its Barostim neo carotid artery pulse stimulator. ...Learn More
FDA allows InVivo Therapeutics to speed up trial enrollment
InVivo Therapeutics has received the FDA's approval to expedite the patient enrollment in its Neuro-Spinal Scaffold trial. ...Learn More
FDA OKs injection system from VEXIM
The Masterflow Injection System developed by VEXIM has obtained marketing authorization in the U.S. from the FDA. ...Learn More
FDA clears 3 devices from Merit Medical Systems
The AEROmini tracheobronchial stent system, the ReSolve biliary locking drainage catheter and the ONE Snare line of ...Learn More
Stent planning tool from Vital Images gains FDA clearance
The FDA has granted Vital Images 510(k) clearance to market its fenestrated stent planning tool. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, 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
I dwell in Possibility.
Emily Dickinson, American ...Learn More
Analysis: Medtech M&A activity surges in 2014
A MassDevice.com analysis found that the value of merger and acquisition deals in the medical device sector increased almost ...Learn More
Funding round brings in $59M for InSightec
A round of Series D financing has pulled in $59 million for InSightec, developer of the EU-approved ExAblate MR-guided ...Learn More
Exact Sciences announces public stock sale
Exact Sciences announced Monday that it is selling 4 million shares in a public offering. ...Learn More
Europe expands approval for Roche's Cobas assays
Roche has earned additional approval from European Union regulators for the use of Cobas MPX and Cobas WNV assays to test ...Learn More
U.K. genomic firm signs distribution deal with AutoGen
LGC, which operates in the U.K., has entered into a distribution deal with AutoGen for undisclosed terms. ...Learn More
FDA approves study of Brainsway's device for PTSD
The FDA has granted Brainsway an investigational device exemption to conduct a 166-patient trial to evaluate the efficiency ...Learn More
Medtronic debuts NovaShield injectable gel for sinus surgery
Medtronic has launched its NovaShield Injectable Nasal Packing and Stent, which is designed for use following functional ...Learn More
Firms win most innovative award for needle safety device
The 2014 DeviceMed award for most innovative device was given to German medtech component maker Raumedic AG and the ...Learn More
FDA clears 3D arthroplasty planning software from EOS
The hipEOS 3D hip arthroplasty planning software developed by orthopedic digital X-ray company EOS Imaging has obtained FDA ...Learn More
Blood test to estimate heart disease risk receives FDA approval
A blood test developed by diaDexus that determines coronary heart disease risk in people with no history of heart disease ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...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
Never mistake motion for action.
Ernest Hemingway, American ...Learn More
Wright Therapy receives $4.4M boost from investors
A group of investors has pumped about $4.4 million into Wright Therapy Products, which developed a device for lymphedema ...Learn More
Equity round brings in $3M for ForSight Vision6
ForSight Vision6, based in Menlo Park, Calif., has pulled in $3 million in an equity round with five undisclosed investors, ...Learn More
K2M Group plans to move headquarters to Va.
K2M Group is moving its headquarters and R&D facility to Leesburg, Va. ...Learn More
Orthopedic device company secures $575K
OrthogenRx, an orthopedic device company, has raised $575,000 in financing from Ben Franklin Technology Partners. ...Learn More
German firm Sygnis pulls in $6.2M in financing
Sygnis, the German developer of the TruePrime Single Cell WGA kit, has closed its rights offering and secured a total of ...Learn More
SDRI enters European distribution deal with joimax
California-based joimax has agreed to to bring Synergy Disc Replacement's SYNERGY Cervical Disc to Germany, Austria and ...Learn More
Firm commences trial for staph ID/R test
Great Basin Scientific is beginning a trial for its staph identification/resistance molecular assay. ...Learn More
New trial begins for Stimwave's chronic back pain device
A new randomized, placebo-controlled trial has been launched by Stimwave Technologies to test the use of its wireless ...Learn More
Alere's rapid HIV test gains FDA waiver
Alere obtained a waiver from the FDA for the expanded use of its Determine HIV-1/2 Ag/Ab Combo test. ...Learn More
FDA review may result in removal of devices from high-risk category
Some devices may be bumped off the highest-risk category after the FDA finishes the review of its premarket approval ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Some of us think holding on makes us strong; but sometimes it is letting go.
Hermann Hesse, German-Swiss writer and ...Learn More
Mass. developer of image management tech obtains $8M
Image Stream Medical has pulled in $8 million from a sole anonymous investor in a new equity offering, according to a ...Learn More
Roche strikes deal to purchase AvanSci Bio's MilliSect products
Roche Diagnostics agreed to acquire the entire MilliSect tissue extraction product line from AvanSci Bio. ...Learn More
Claritas Genomics taps NextCode Health for Dx interpretations
Cambridge, Mass.-based Claritas Genomics, a provider of clinical diagnostic tests including the ClariFocus Exome for ...Learn More
Swedish genomic firm gains rights to license ValidPrime technology
Tataa Biocenter, which is based in Goteborg, Sweden, has struck a licensing deal with the French Institute for Health and ...Learn More
Abbott wins CE mark approval for Iridica platform
Abbott has earned the CE mark for its Iridica pathogen detection platform, which can determine even infrequent pathogens. ...Learn More
EU approves St. Jude's Quadra Allure MP pacemaker
European regulators have granted CE mark approval to St. ...Learn More
Transcatheter Technologies announces new transcatheter valve
Transcatheter Technologies, maker of the Trinity transcatheter aortic valve implant, announced the newest version to its ...Learn More
Cianna Medical wins FDA nod for breast tumor device
The FDA has granted clearance for California-based Cianna Medical's Strut-Adjusted Volume Implant SCOUT system, a breast ...Learn More
FDA approves endoprosthesis from Gore Medical
The GORE VIABAHN endoprosthesis, developed by Flagstaff, Ariz.-based Gore Medical, has obtained FDA approval for use in ...Learn More
Defibrillator leads from Medtronic gain premarket approval
The FDA has given premarket approval to Medtronic for new additions to its Attain Performa line of quadripolar cardiac ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
The future cannot be predicted, but futures can be invented.
Dennis Gabor, Hungarian-British electrical engineer and ...Learn More
Medtech sector IPO filings jumped in 2014, analysis shows
An analysis by MassDevice.com found that the medical device sector filed for 25 initial public offerings this year, up from ...Learn More
Minn. lumbar spinal device maker receives $2M boost
An equity-and-options round has pulled in $2 million for Zyga Technology, maker of lumbar spinal surgical devices, including ...Learn More
UTI Dx startup lands investment from BioGenerator
BacterioScan, a startup working on a urinary tract infection diagnostics device, has received an undisclosed investment from ...Learn More
NIH backs development of Ebola rapid detection assay
David Alland, a researcher from Rutgers New Jersey Medical School, has received a $640,000 supplement grant from the NIH to ...Learn More
Synergetics pays $13.5M for U.K. eye surgical tool firm
Synergetics USA announced its $13.5 million acquisition of Sterimedix, a British company specializing in eye surgical tools. ...Learn More
Intrinsic Therapeutics wraps up trial enrollment for anular closure device
Intrinsic Therapeutics has finished enrolling patients for a trial evaluating its Barricaid anular closure device for lumbar ...Learn More
Hunter Medical unveils elbow surgical assist device
The ElbowLOC Arm Positioning System is now available commercially, according to Hunter Medical. ...Learn More
Patient, industry groups weigh in on FDA policies
AdvaMed, the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America joined patient ...Learn More
AmpliVue molecular Dx assay from Quidel wins FDA nod
The AmpliVue Bordetella Assay developed by Quidel has obtained clearance from the FDA. ...Learn More
FDA delays premarket review of VertiFlex spine implant
The FDA has moved an advisory panel meeting for VertiFlex's Superion spine implant to Feb. 20 for undisclosed reasons. ...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 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
What concerns should medical device companies focus on in the coming year?
A painting that is well-composed is half-finished.
Pierre Bonnard, French ...Learn More
N.J. ischemia implantable device maker raises over $10.2M in debt offering
Angel Medical Systems has obtained over $10.2 million toward its goal of $20.5 million in a debt offering, according to a ...Learn More
CareFusion plans to vote on Becton Dickinson merger in January
CareFusion has scheduled a shareholders meeting Jan. ...Learn More
Welch Allyn buys assets of Neb. remote patient monitoring firm
Welch Allyn announced it has acquired the assets of HealthInterlink, the Omaha, Neb.-based maker of the Beacon 2.0 remote ...Learn More
French molecular Dx firm gets $3.8M boost
Novocyte has secured $3.8 million in a private equity financing round joined by Alto Invest. ...Learn More
Canada OKs spinal surgery implant from Aurora Spine
Aurora Spine's ZIP MIS Interspinous Fusion System was granted the Health Canada Medical Device License. ...Learn More
Trial enrollment for Biotronik's ProMRI pacemaker completed
Biotronik announced that patient enrollment and planned MRI studies in phase B of its analysis of its ProMRI pacemakers have ...Learn More
Positive results reported in 2 studies of Medtronic's stent graft
Medtronic's Endurant AAA stent graft demonstrated promising results in two long-term studies. ...Learn More
FDA clears retinal imaging system from CenterVue
The FDA has given CenterVue 510(k) clearance to market Eidon, a retinal imaging system. ...Learn More
Siemens seeks FDA clearance for CT lung cancer screening
Siemens Healthcare has submitted an application seeking 510(k) clearance from the FDA to market its Lung Low Dose Protocol ...Learn More
Focus Diagnostics gets additional clearance for flu strain assays
Focus Diagnostics has received additional clearance from the FDA for eight other influenza strains on its Simplexa Flu A/B & ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, 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
What trend in medical device technology had the biggest impact in the past year?
Respect your efforts, respect yourself. Self-respect leads to self-discipline. When you have both firmly under your belt, that's real power.
Clint Eastwood, American actor and ...Learn More
Amedica brings in nearly $13M from IPO
Amedica raised close to $13 million in gross proceeds from its now-closed underwritten public offering that started Nov. 26. ...Learn More
CardioKinetix secures $50M in funding, exclusive acquisition deal
CardioKinetix, a developer of cardiac devices including the Parachute ventricular partitioning device, has received $50 ...Learn More
Orthopedic surgery kit developer gets $2.2M boost
A private stock sale has pulled in $2.2 million for Flower Orthopedics, according to a Securities and Exchange Commission ...Learn More
Symmetry Medical completes spinout of surgical unit
Symmetry Medical has successfully spun off its surgical instrumentation unit, Symmetry Surgical. ...Learn More
European firm purchases Boston Heart Diagnostics
Eurofins Scientific, a Luxembourg-based bioanalytical testing firm, has agreed to acquire Boston Heart Diagnostics for $140 ...Learn More
Victorian Clinical Genetics Services, Illumina collaborate on prenatal assay
A partnership deal to create a noninvasive prenatal test has been reached between Illumina and Victorian Clinical Genetics ...Learn More
EU approves HIV, HCV molecular Dx from Roche
European regulators have granted Roche CE mark approval for its Cobas HIV-1 and HCV assays. ...Learn More
ExThera's blood-filtering device eliminates drug-resistant bacteria in study
ExThera Medical has released data from a study which evaluated its Seraph blood-filtering device. ...Learn More
Siemens introduces updated SOMATOM Definition Edge CT
Siemens has launched an upgraded version of the SOMATOM Definition Edge CT. ...Learn More
Prosigna assay from NanoString receives new FDA labeling
The FDA has issued an update for the labeling of NanoString's Prosigna Breast Cancer Gene Signature Assay, which received ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Which medical device issue do you encounter most often?
Knowing your own darkness is the best method for dealing with the darknesses of other people.
Carl Jung, Swiss ...Learn More
Becton Dickinson looks to offer $6.2B in senior notes
Becton Dickinson announced that it will sell five sets of senior unsecured bonds worth a total of $6.2 billion, which are ...Learn More
Robotic exoskeleton developer obtains nearly $23M in funding
Ekso Bionics, a firm developing an FDA-approved wearable robotic exoskeleton to help paralyzed or movement-impaired patients ...Learn More
Symmetry Medical's merger, business unit sale get shareholders' OK
Shareholders of Symmetry Medical have voted in favor of approving the company's pending merger with TecoStar, Tecomet and ...Learn More
Qiagen, Altona sign distribution deal for Ebola testing kit
Qiagen has agreed to globally distribute Altona Diagnostics' RealStar Ebolavirus RT-PCR Kit 1.0, a testing kit capable of ...Learn More
Report: BRIC diagnostic imaging markets could hit $7.6B by 2018
A MarketsandMarkets report predicts that the diagnostic imaging markets in Brazil, Russia, India and China will reach $7.6 ...Learn More
Roche to purchase U.S. molecular Dx firm
Switzerland-based Roche Holdings agreed to purchase U.S. ...Learn More
German sequencing, Dx firm plans to restructure
GATC Biotech, a sequencing services and diagnostics firm based in Germany, said it plans to reorganize its business into ...Learn More
Study links St. Jude Medical's Optim leads to lower failure rates
St. ...Learn More
Calif. hospital installs Mazor Robotics Renaissance system
Long Beach, Calif.-based Dignity Health St. ...Learn More
Fiagon wins FDA clearance for extended instrument set
The ear, nose and throat extended instrument set developed by Fiagon has obtained 510(k) clearance from the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...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
There are dark shadows on the earth, but its lights are stronger in the contrast.
Charles Dickens, British ...Learn More
Mass. cartilage repair device firm lowers IPO target to $57.2M
Massachusetts-based Histogenics is looking to obtain $57.2 million with the launch of its initial public offering Wednesday, ...Learn More
Calif. replacement heart valve firm gets $32M boost
A funding round has brought in $32 million for Santa Rosa, Calif.-based Direct Flow Medical. ...Learn More
Teleflex enters marketing deal with group purchasing organization
Teleflex has agreed to supply Premier's network of hospitals and health care providers with its current and future dialysis ...Learn More
eBioscience strikes distribution agreement with U.K. supplier
Affymetrix unit eBioscience has struck a distribution deal with The Binding Site, a diagnostic tools supplier based in the ...Learn More
Danish Dx firm secures exclusive license for prostate cancer biomarkers
Aarhus University Hospital has given Exiqon, a Denmark-based diagnostics maker, an exclusive license to prostate cancer ...Learn More
Podcast: B. Braun Medical CEO on the medical device tax, health care law and innovation
Caroll Neubauer, the CEO of B. ...Learn More
Trial enrollment for Spinal Modulation's neurostimulator system closed
Spinal Modulation has wrapped up patient enrollment for a clinical trial evaluating its Axium Neurostimulator System, an ...Learn More
Firms partner for cancer immune response biomarker
An agreement between OncoSec Medical, PerkinElmer and the University of California, Los Angeles, will focus on creating ...Learn More
Spineart gains approval from FDA for posterior axial device
The FDA has given Spineart 510(k) clearance to market the ROMEO2 PAD, a posterior axial device with 30 degrees of plate ...Learn More
Paragonix wins additional FDA clearance for organ transport system
Paragonix Technologies, the developer of the Sherpa Pak organ transport systems, has obtained additional FDA clearance 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
Our finest moments are most likely to occur when we are feeling deeply uncomfortable, unhappy or unfulfilled. For it is only in such moments, propelled by our discomfort, that we are likely to step out of our ruts and start searching for different ways...
M. Scott Peck, American ...Learn More
Minn. maker of fracture implant device secures $24M
A round of Series AA financing has pulled in $24 million for Conventus Orthopaedics. ...Learn More
Healthtell receives NIH funding to evaluate brain cancer Dx
The NIH has awarded a $225,000 Small Business Innovation Research grant to Healthtell to finance an effectiveness study on ...Learn More
US Medical Innovations signs distribution deal with CrossLink Surgical
US Medical Innovations has entered into a distribution deal with CrossLink Surgical. ...Learn More
N-of-One partners with cancer genetics Dx firm
N-of-One has entered into an agreement with NeoGenomics for an undisclosed sum to interpret test results generated by the ...Learn More
Swiss medtech firm obtains $34M in Series B financing
Xeltis, whose first product is a replacement pulmonary valve that can stimulate regeneration of new coronary valves and ...Learn More
Integrated DNA Technologies, Ubiquitome collaborate on handheld Ebola assay
Integrated DNA Technologies has agreed to work with Ubiquitome, a New Zealand-based startup, to create a handheld Ebola test ...Learn More
Device provides docs with real-time feedback on radiation exposure
Interventional cardiologists who wore the Bleeper SV radiation monitoring device while in the cath lab were exposed to lower ...Learn More
Spinal fusion system from Benvenue Medical wins FDA nod
The Luna 360 Interbody Fusion System developed by Benvenue Medical has obtained 510(k) clearance from the FDA. ...Learn More
FDA clears injectable pain relief device from Stimwave
The FDA has given Stimwave clearance to market its Freedom Spinal Cord Stimulator System in the U.S. ...Learn More
Delphinus' SoftVue system gains additional FDA clearance
The FDA has granted Delphinus Medical Technologies an additional 510(k) clearance for its SoftVue system, this time for the ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...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
The one thing all famous authors, world-class athletes, business tycoons, singers, actors, and celebrated achievers in any field have in common is that they all began their journeys when they were none of these things.
Mike Dooley, American ...Learn More
Medtronic raises $17B in seven-part debt offering
Medtronic has secured $17 billion through a seven-tranche debt offering to help fund the company's $42 billion acquisition ...Learn More
Minn. medical device firm gets $7.5M boost
Interrad Medical, a medical device firm based in Plymouth, Minn., has obtained $7.5 million in a financing round led by ...Learn More
Philips gains license rights to RaySafe S1 X-ray dose system
Royal Philips was granted an exclusive license for the RaySafe S1 X-ray dose-managing system developed by Unfors RaySafe, a ...Learn More
23andMe wins CE mark approval for genetic analysis kit
European regulators have granted CE mark approval for 23andMe's Personal Genome Service spit kits, which performs genetic ...Learn More
EU approves Aptima HIV-1 Quant Dx assay from Hologic
Hologic has earned the CE mark for its Aptima HIV-1 Quant Dx assay, an HIV viral load assay that features real-time, ...Learn More
Trial enrollment for Cardiovascular Systems' atherectomy system closed
Cardiovascular Systems has wrapped up patient enrollment in Japan for a clinical study on its second-generation micro-crown ...Learn More
Thoratec wraps up trial enrollment for heart pump
Pleasanton, Calif.-based Thoratec has finished enrolling patients for a clinical trial evaluating its HeartMate III left ...Learn More
J&J unit wins FDA approval for insulin pump system
Animas, a subsidiary of Johnson & Johnson Diabetes Solutions, has obtained FDA approval for its Animas Vibe insulin pump and ...Learn More
FDA OKs in vitro Dx assay from Cepheid
Cepheid has secured FDA clearance to market its Xpert Norovirus assay, which runs on the company's GeneXpert platform. ...Learn More
FDA clears Turnpike catheters from Vascular Solutions
The FDA granted Vascular Solutions 510(k) clearance to market its Turnpike catheter, which features a dual-layer coil inside ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
The bird a nest, the spider a web, man friendship.
William Blake, British painter and ...Learn More
FTC, EU approve $43B Medtronic-Covidien deal
Medtronic received approval from the U.S. ...Learn More
Genomics gets $12.8M boost for genomic sequencing analysis
Genomics has secured $12.8 million in a private financing round that included the IP Group, the University of Oxford and ...Learn More
Brain injury device maker takes in almost $4.2M in debt financing
X2 Biosystems, a brain injury device developer based in Seattle, has brought in about $4.2 million through a debt and ...Learn More
Diagnostics innovation hub launched in Singapore
A Diagnostics Development Hub has been created by the Singapore Agency for Science and Technology Research to speed up the ...Learn More
Neuromod wins approval for tinnitus device in Europe
A multisensory device for treating tinnitus developed by Neuromod Devices has obtained CE mark approval in Europe. ...Learn More
U.S. patent issued to Acertara's probe testing device
The number of U.S. ...Learn More
Centinel Spine's new lumbar interbody fusion device due out in early 2015
Centinel Spine announced that its newest STALIF Family Lumbar Integrated Interbody fusion device, the MIDLINE II, will be ...Learn More
Konica Minolta introduces portable ultrasound system
Sonimage HS1, a handheld ultrasound system featuring an advanced transducer and a broadband linear probe, was launched by ...Learn More
AdvaMed commends Japanese medtech regulations
Japan's adoption of new medical device regulations will make the regulatory process easier for device manufacturers, said ...Learn More
For more:
Read the AdvaMed press release for President and CEO Stephen Ubl's comments about the new medtech regulatory framework in ...Learn More
Enhanced CT imaging system from Philips wins FDA nod
The IQon Spectral CT system developed by Royal Philips has received 510(k) clearance from the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
Bring ideas in and entertain them royally, for one of them may be the king.
Mark Van Doren, American poet and ...Learn More
B. Braun drops plans to expand headquarters over device tax costs
Series C round pulls in $5M for iHear Medical hearing aids
iHear Medical has obtained $5 million in a Series C financing round. ...Learn More
Thermo, Samsung to work on point-of-care Dx solutions
Thermo Fisher Scientific and Samsung Electronics have partnered to create and commercialize point-of-care diagnostic ...Learn More
ProMedica opens medtech startup incubator in Ohio
ProMedica Health System has begun the ProMedica Innovations incubator for medical device and bioinformatics startups in ...Learn More
InSightec gets Japanese approval for ExAblate system
Japanese regulators have given InSightec clearance to market ExAblate, a magnetic resonance-guided, focused ultrasound ...Learn More
Device could reduce pressure, pain during mammograms
A team of researchers from the Netherlands has come up with a device that could reduce pain experienced during breast ...Learn More
New patent issued to Spineology for spinal fusion system
Spineology has secured a patent for a percutaneous spinal interbody fusion system, covering implants, instrumentation and ...Learn More
FDA clears lumbar spinal device from Interventional Spine
The FDA has granted Interventional Spine clearance for the Lateral Opticage Expandable Intervertebral Body Fusion Device. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities. ...Learn More
AdvaMed SmartBrief will not publish Thursday and Friday
In observance of Thanksgiving in the U.S., AdvaMed SmartBrief will not publish Thursday and Friday. ...Learn More
Courage is the capacity to confront what can be imagined.
Leo Rosten, Russian-American teacher and ...Learn More
Second Sight earns over $36M from IPO
The initial public offering last week of Second Sight Medical pulled in $36.2 million for the company after the underwriter, ...Learn More
Maker of cloud-based monitoring platform obtains $17M
The second tranche of InfoBionic's Series B funding round has pulled in $17 million, which it will use to advance the U.S. ...Learn More
Kelyniam Global buys implantable device maker
Kelyniam Global, a cranial and facial implant maker based in Canton, Conn., announced its acquisition of Med-Ally for an ...Learn More
Horizon Discovery enters partnership with Adarza Biosystems
Horizon Discovery Group has agreed to a licensing and supply deal with Adarza Biosystems for an undisclosed sum. ...Learn More
German molecular Dx firm obtains $18M in funding extension
Curetis has brought in $18 million in a Series B financing round extension through the investments of Qiagen and the LSP ...Learn More
FDA OKs study of Cerus' plasma treatment system
The FDA has granted Cerus an investigational device exemption for clinical studies of its INTERCEPT Blood System, a ...Learn More
Microfluidic chip reduces amount of blood needed for testing
Scientists at the Indian Institute of Technology-Bombay have designed a microfluidic chip for blood separation that requires ...Learn More
FDA clears balloon catheter from Covidien
The FDA has given Covidien 510(k) clearance to market the Fortrex PTA balloon catheter. ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...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
The secret of business is to know something that nobody else knows.
Aristotle Onassis, Greek shipping ...Learn More
Calif. bioresorbable stent firm gets $25M boost
Reva Medical has secured $25 million to support current operations and advance its products, the San Diego-based firm ...Learn More
Aneurysm device startup obtains $7M in funding
Aortica, a startup developing a patient-specific device to treat abdominal aortic aneurysms, has raised $7 million in a ...Learn More
U.S. antitrust waiting period ends for Becton Dickinson-CareFusion deal
Becton Dickinson now awaits approval from CareFusion shareholders in its bid to buy the company, as well as the OK from ...Learn More
CareDx ends lupus flare test collaboration with LabCorp
CareDx and Laboratory Corp. ...Learn More
EU approves Covidien's Nellcor oxygen monitor
European regulators have granted CE mark approval for Covidien's Nellcor bedside SpO2 patient monitoring device, which ...Learn More
CoorsTek Medical purchases Italian medtech firm
CoorsTek Medical announced its acquisition of Nanosurfaces Industries, the Italian device manufacturing unit of European ...Learn More
Faxitron to introduce high-resolution detector for new systems
Faxitron Bioptics is set to launch a high-resolution, complementary metal-oxide semiconductor digital detector for its ...Learn More
FDA clears BrainScope's brain trauma device
The Ahead 100 device, developed by Bethesda, Md.-based company BrainScope, has received clearance from the FDA. ...Learn More
FDA extends timeline for UDI marking compliance for certain orthopedic implants
Labelers of certain single-use orthopedic implants will have until Sept. ...Learn More
Low-dose portable X-ray system from Kubtec wins FDA OK
Kubtec has gained approval from the FDA to launch its KUB 250, a portable digital X-ray system designed to cut radiation ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...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
A broken bone can heal, but the wound a word opens can fester forever.
Jessamyn West, American ...Learn More
BioNano Genomics gets $53M boost to advance Irys platform
BioNano Genomics, a San Diego-based developer of genome mapping platforms, has obtained $53 million in a Series C funding ...Learn More
Funding round brings in $7.5M for molecular Dx startup
A round of Series A financing headed by Sherpa Ventures has pulled in $7.5 million for molecular diagnostics startup Cue. ...Learn More
Hospital GPO awards supply contract to Medical Imaging Solutions International
Medical Imaging Solutions International has entered into a supply agreement with Premier, a hospital group purchasing ...Learn More
New Zealand, Australia drop proposal to form joint regulatory body
A plan by New Zealand and Australia to create a single agency to regulate the medical device sector in both countries has ...Learn More
Canada releases guidance for new medtech license applications
Medical device manufacturers are required to submit license applications for Class III and Class IV devices in Canada via ...Learn More
Firms to develop advanced sequencing technology for infection monitoring
Illumina and bioMerieux agreed to collaborate in the development of applications for microbiology sequencing technologies. ...Learn More
Mich. health system to use firm's proton therapy system
The ProteusOne single-room proton therapy device developed by Ion Beam Applications will be installed at the Beaumont Health ...Learn More
SpineDriver to launch battery-powered device for drilling into spine
SpineDriver unveiled its newest battery-powered device to drill and drive pedicle screws into the spine at a spinal care ...Learn More
Accuray reports N.Y. installation of CyberKnife M6 system
Accuray has installed its CyberKnife M6 radiosurgery system at Winthrop-University Hospital's NYCyberKnife Center in ...Learn More
FDA OK sought by Great Basin Scientific for Group B strep test
Great Basin Scientific has submitted a 510(k) clearance application to the FDA for use of its Group B strep test in ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
Men stumble over pebbles, never over mountains.
H. Emilie Cady, American ...Learn More
IPO pulls in $31.5M for Second Sight
An initial public offering Wednesday brought in $31.5 million for artificial retina developer Second Sight Medical Products. ...Learn More
Biomarker firm obtains $2.3M in funding for autism study
The Nancy Lurie Marks Family Foundation has given Stemina Biomarker Discovery $2.3 million to finance its study of autism ...Learn More
Company receives NIH funding to improve antibiotic delivery of implants
The NIH has given a $150,000 grant to Oxford Performance Materials to fund a study on treating infections caused by ...Learn More
Brazil seeks feedback on medtech quality inspections proposal
Medical device manufacturers may opt to provide feedback on how their quality management inspections were conducted under ...Learn More
Genetic Technologies wraps up sale of Australian subsidiary
The sale of Genetic Technologies' Australian Genetics unit to Specialist Diagnostics Services for $1.7 million has been ...Learn More
CardioMEMS device from St. Jude reduces 30-day readmissions
Data from St. ...Learn More
Boston Scientific's Synergy stent passes Evolve II trial
Boston Scientific's Synergy stent passed the Evolve II trial, where it was put against drug-eluting stent Promus, the ...Learn More
OrthoGrid launches device for better total hip replacement
HipGrid, an FDA-approved device designed for better positioning and alignment during total hip replacement, has been ...Learn More
Colonoscopy imaging device from Avantis wins FDA OK
The Third Eye Panoramic device, developed by Avantis Medical Systems, has obtained 510(k) clearance from the FDA. ...Learn More
FDA gives green light to IlluminOss' bone fracture device study
The FDA has given IlluminOss Medical conditional clearance to conduct a clinical study to test the use of its photodynamic ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. ...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
I think a hero is any person really intent on making this a better place for all people.
Maya Angelou, American ...Learn More
Royal Philips agrees to sale of InnerCool business to Zoll Medical
Zoll Medical will acquire Royal Philips' InnerCool temperature management business, including the FDA-cleared Accutrol ...Learn More
Genetic Signatures aims to bring in $13.1M in IPO
Genetic Signatures, the molecular diagnostics company behind the EasyScreen PCR pathogen detection kits, is looking to ...Learn More
New heart devices boost Medtronic's Q2 revenue
Medtronic saw a 4% increase in its second-quarter revenue to $4.37 billion, driven in part by sales from its new heart ...Learn More
Wis. blood center taps N-of-One for oncology testing services
The BloodCenter of Wisconsin has entered into an oncology testing partnership with N-of-One for undisclosed terms. ...Learn More
Zimmer agrees to longer EU review of Biomet deal
The European Commission has reached an agreement with Zimmer to extend an antitrust review of the company's pending ...Learn More
Partnership aims to investigate arrhythmia in dialysis patients
DaVita Healthcare Partners will work with Medtronic on a pilot effort to use the latter's Reveal LINQ Insertable Cardiac ...Learn More
FDA clears spinal fusion implant from Aurora Spine
The ZIP 51, developed by Aurora Spine and part of the company's Aurora Spine MIS Fusion System, has obtained 510(k) ...Learn More
Toshiba to launch updated CT and new PET/CT systems
Toshiba has announced updates to its Aquilion CT scanners and the release of its Celesteion PET/CT system. ...Learn More
Industry groups call for extension of tax credits
Over 500 businesses and industry groups, including AdvaMed, have signed a letter to Congress asking for the renewal of some ...Learn More
Rapid MRSA detection assay from AdvanDx wins FDA nod
The FDA has given AdvanDx 510(k) clearance to market its mecA XpressFISH assay for detecting methicillin-resistant and ...Learn More
PMA Submissions Workshop
Thursday, Feb. 26, to Friday, Feb. 27Loews Madison Hotel, Washington, D.C. ...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
It is always our own self that we find at the end of the journey. The sooner we face that self, the better.
Ella Maillart, Swiss travel ...Learn More
Medtronic to hold shareholder vote in January on Covidien buy
Medtronic has scheduled a special shareholder meeting Jan. ...Learn More
Regenerative medicine firm targets $60M in IPO
Waltham, Mass.-based Histogenics is looking to obtain $60 million with its initial public offering. ...Learn More
Valeant to pay up to $20M for Nicox's U.S. ophthalmic Dx unit
Valeant Pharmaceuticals has agreed to acquire Nicox's U.S. ...Learn More
Partnership aims to develop in vitro Dx kit for MRD
Sequenta has agreed to work with Illumina to develop and market an in vitro diagnostic kit that can be used to detect and ...Learn More
Protagen taps Qiagen in long-term companion Dx deal
An agreement reached by Protagen and Qiagen will focus on further developing protein-based companion diagnostic tests to ...Learn More
Bone Therapeutics to develop spinal fusion device with French firm
French firm Kasios will combine its synthetic microgranules bone substitute with Bone Therapeutics' ALLOB allogeneic ...Learn More
Covidien's VenaSeal offers promising treatment for chronic leg vein disorders
A study conducted by Covidien shows that the effectiveness of its new VenaSeal system as a treatment for chronic leg vein ...Learn More
NFL funds further development of concussion detection device
The University of Miami's Miller School of Medicine has secured a $500,000 grant from the National Football League, which it ...Learn More
EKF Diagnostics launches hemoglobin analyzer
EKF Diagnostics has introduced its DiaSpect TM point-of-care hemoglobin analyzer that can deliver results in a second. ...Learn More
Medtech firms express concern over EPA stance on sterilizer
The Environmental Protection Agency's draft assessment concluding that ethylene oxide, which is used to sterilize medical ...Learn More
510(k) Submissions Workshop
Monday, Feb. 23, to Tuesday, Feb. 24Loews Madison Hotel, Washington, D.C. ...Learn More
IDE Submissions Workshop
Wednesday, Feb. 25Loews Madison Hotel, Washington, D.C. ...Learn More
When nothing seems to help, I go look at a stone-cutter hammering away at his rock perhaps a hundred times without as much as a crack showing in it. Yet at the hundred and first blow it will split in two, and I know it was not that blow that did it,...
Jacob Riis, Danish-American social ...Learn More
Heart valve implant maker obtains nearly $11M boost
JenaValve Technology has pulled in almost $11 million in a round of Series C financing, raising a total of $73.4 million in ...Learn More
Boston Scientific scores reimbursement wins for heart device
Boston Scientific has announced that starting Jan. ...Learn More
DermTech files to withdraw IPO proposal
DermTech, a California-based company specializing in tests to diagnose melanoma and other skin conditions, has filed to ...Learn More
Unilife taps Flextronics to expand production capacity
Unilife, which specializes in drug-delivery systems, has entered a global strategic deal with Flextonics for an undisclosed ...Learn More
Beckman Coulter enters molecular Dx deal with Seegene
Seegene, a South Korea-based firm, has agreed to a molecular diagnostics deal with Beckman Coulter to produce reagents ...Learn More
Nico enters partnership with Canadian firm for neurosurgery system
Nico and Synaptive Medical, a Toronto-based 3D visualization company, have struck a deal to work together on a neurosurgery ...Learn More
Study underway for Zyga's lumbar facet pain syndrome device
A patient at the Greater Baltimore Medical Center has become the first to be implanted with the Glyder Facet Restoration ...Learn More
Aethlon's Hemopurifier reduces Ebola viral load, case report suggests
Doctors from Goethe University in Germany reported at the Kidney Week conference that Aethlon's Hemopurifier helped reduce ...Learn More
FDA authorizes emergency use of Altona's Ebola testing kit
Altona Diagnostics announced that the FDA has authorized the emergency use of its RealStar Ebolavirus RT-PCR Kit 1.0, an in ...Learn More
FDA taps medical center to assist in Sentinel drug, device monitoring program
The Vanderbilt University Medical Center was enlisted by the FDA to offer research expertise to the agency's Sentinel System ...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
Failure will never overtake me if my determination to succeed is strong enough.
Og Mandino, American ...Learn More
U.S., EU regulators OK Endurant IIs stent graft from Medtronic
Medtronic's new Endurant IIs AAA endovascular stent graft, which is used to treat abdominal aortic aneurysms, has received ...Learn More
Monteris obtains $30M for robotic laser surgery platform
The first tranche of a Series B funding round has brought in $30 million for Minnesota-based Monteris Medical. ...Learn More
Medtronic grants natriuretic peptide rights to Capricor
Capricor Therapeutics secured the patent rights for the formulation and delivery of natriuretic peptides from Medtronic for ...Learn More
C. difficile test drives Q3 revenue growth for Great Basin
Utah-based Great Basin Scientific generated $404,390 in revenue during the third quarter, compared with $223,470 in the same ...Learn More
New Oncology signs cancer Dx deal in Singapore
The National Cancer Centre Singapore has entered into a cancer diagnostics partnership with Germany-based New Oncology for ...Learn More
Molecular Dx firm obtains up to $3.3M for Ebola diagnostic test
The Bill & Melinda Gates Foundation and the Paul G. ...Learn More
Roche's Group A strep test scores FDA clearance
The FDA has cleared Roche to market a polymerase chain reaction-based test that can identify the presence of Group A ...Learn More
Integra announces U.S. release of expandable interbody device
Integra LifeSciences said its first expandable interbody device, the FDA-cleared Integra Expandable Interbody System, is now ...Learn More
Lawmaker: Repeal of medical device tax could come with Republican-led Congress
A good way to create jobs and stimulate the economy is to repeal the 2.3% medical device tax, and it's a move that has ...Learn More
Industry exec commends proposed FDA oversight of LDTs
The FDA's proposed risk-based oversight of laboratory-developed tests would guarantee the effectiveness of the tests and ...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
Clarification
A summary in AdvaMed SmartBrief on Wednesday should have said Lantheus Medical Imaging postponed its plans for an initial ...Learn More
In helping others, we shall help ourselves, for whatever good we give out completes the circle and comes back to us.
Flora Edwards, American ...Learn More
Report: Medtech sector saw more but lower-value M&A deals in Q3
A PricewaterhouseCoopers report finds that the medical device sector signed 13 merger and acquisition deals during the third ...Learn More
IPO brings in nearly $145M for Nevro
Nevro, maker of the Senza spinal cord stimulation system, has obtained $144.9 million in an initial public offering. ...Learn More
Debt funding round nets $16M for Spiracur
Spiracur, the company behind the SnaP negative-pressure wound therapy device, has secured $16 million in debt financing from ...Learn More
Precision Therapeutics rebrands, appoints new execs
Cancer diagnostics firm Precision Therapeutics has pulled in $60 million through a financing round and adopted a new ...Learn More
Intarcia signs distribution deal with French firm Servier
Servier, a pharmaceutical company based in France, has struck a multimillion-dollar distribution deal with Intarcia ...Learn More
InGen to offer One Lambda's transplant Dx tests in France
One Lambda has renewed its distribution deal with InGen, an affiliate of Diaxonhit, for undisclosed terms. ...Learn More
Realizing the value of med-tech innovations
Why have med tech innovators been hesitant to bust through conventional device price ceilings and really go after the money ...Learn More
DNA test detects rejection risk in kidney transplant patients
Researchers at the University of California, San Francisco, and the University of Cincinnati have developed a genetic test ...Learn More
FDA clears Titan Spine's Endoskeleton implant line
The FDA has granted Titan Spine 510(k) clearance to market its Endoskeleton implant line, which features the firm's ...Learn More
Republican move to repeal device tax expected
The GOP's Senate majority win during last week's elections means Sen. ...Learn More
Vertebral body replacement device from K2M wins FDA nod
The CAPRI Corpectomy Cage System, developed by K2M, has obtained 510(k) clearance from the FDA. ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
It is not the mountain we conquer, but ourselves.
Edmund Hillary, New Zealand ...Learn More
Lantheus plans second IPO attempt
Lantheus Medical Imaging, which makes medical imaging isotopes, announced plans to file for an initial public offering, ...Learn More
Qiagen signs companion Dx deal with Novartis
Qiagen has agreed to work with Novartis to create and market companion diagnostics for the latter's current product line, as ...Learn More
IDT gains licensing rights to EliTech's qPCR probes
Integrated DNA Technologies will manufacture and offer EliTech's MGB Eclipse qPCR probes under a licensing deal reached ...Learn More
CytoSorbents enters partnership with global cardiac surgery company
An unnamed global cardiac surgery company has agreed to work with CytoSorbents to study the use of its CytoSorb cytokine ...Learn More
AdvaMed establishes new outpost in Shanghai
AdvaMed held a ceremony in Beijing to officially open its new office in Shanghai. ...Learn More
For more:
Read the AdvaMed press release about the opening of its representative office in Shanghai, ...Learn More
ViewRay's MRI-based radiotherapy device wins approval in Europe
An MRI-guided radiation therapy device developed by ViewRay has obtained CE mark approval in Europe. ...Learn More
Minimally invasive spinal implant market poised for growth in Latin America
The market for minimally invasive spinal implants in Latin America could be worth $60.7 million by 2019, a report from ...Learn More
New blood test checks for beta amyloid buildup
Scientists have created a blood test that assesses beta amyloid burden, and they believe it will aid research into the ...Learn More
FDA OKs spinal osteosynthesis rod from Medicrea
The FDA has given Medicrea Group 510(k) clearance to market its UNiD system, a spinal osteosynthesis rod that can be ...Learn More
Lombard's U.K. cleanroom facility gets FDA clearance
The FDA has cleared Lombard Medical to begin manufacturing Aorfix endovascular stent grafts at the firm's new cleanroom ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...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
Progress lies not in enhancing what is, but in advancing toward what will be.
Kahlil Gibran, Lebanese artist, poet and ...Learn More
Medtronic signs loan package worth $16.3B
Medtronic has secured a loan package worth $16.3 billion, which the company said will be used to support its pending ...Learn More
IPO pulls in $19.1M for brain stimulation device firm
An initial public offering has brought in $19.1 million for Nexstim. ...Learn More
CareDx posts 16% year-over-year revenue increase in Q3
CareDx, which specializes in molecular diagnostics, reported a 16% year-over-year increase in its third-quarter revenues to ...Learn More
Japanese regulator approves MRI-safe ICD from Medtronic
The Japanese Ministry of Health, Labor and Welfare gave its approval to Medtronic's Evera MRI SureScan implantable cardiac ...Learn More
ACD enters partnership for RNAscope test development
Advanced Cell Diagnostics has struck a development deal with MicroMatrices for undisclosed terms. ...Learn More
Orthofix kicks off bone-stimulating device studies
Orthofix has begun its large-scale U.S. ...Learn More
Device sorts circulating tumor cells in the blood to predict spread of tumor
Scientists at the University of Toronto have designed a device that uses nanoparticles to sort circulating tumor cells into ...Learn More
Cervical plate from Zimmer Spine wins FDA nod
The FDA has granted 510(k) clearance for Zimmer Spine's Optio-C Anterior Cervical Plate, which is used in conjunction with ...Learn More
Guidance explaining molecular Dx device regulation issued by FDA
The FDA has issued guidelines governing the approval or clearance of certain molecular diagnostic systems. ...Learn More
ImThera gets FDA OK to launch trial of sleep apnea device
ImThera Medical has received approval from the FDA to conduct clinical trials of its aura6000, designed to treat obstructive ...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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
The excellence of a gift lies in its appropriateness rather than in its value.
Charles Dudley Warner, American ...Learn More
Funding round brings in $15M for OrthAlign
A round of financing headed by Mutual Capital Partners and River Cities Capital Funds has pulled in $15 million for ...Learn More
Report: Small bone orthopedics market could hit $4B by 2020
A report from iData projects that by 2020, the U.S. ...Learn More
Molecular Dx startup obtains $1.1M in financing
Prostate Management Diagnostics, a molecular diagnostics startup founded by the Peter Michael Foundation, has raised almost ...Learn More
CryoVascular signs distribution deal with Vascular Solutions
The PolarCath cryoplasty device, developed by Dr. ...Learn More
J&J, S. Korea collaborate to boost medtech industry
Johnson & Johnson Medical Korea and South Korea's Ministry of Health and Welfare have entered an agreement to invest $25 ...Learn More
German experts develop degradable orthopedic implants
Scientists from the Fraunhofer Institute for Manufacturing Technology and Advanced Materials in Germany have developed ...Learn More
DePuy Synthes launches hybrid arthroscopic anchor
The GRYPHON PROKNOT Anchor is available commercially, according to DePuy Synthes, a unit of Johnson & Johnson. ...Learn More
Aerocrine's device to treat asthma cleared by FDA
The FDA has cleared Aerocrine to market the Niox Vero system, which measures fractional exhaled nitric oxide in about a ...Learn More
FDA OKs SpineFrontier to develop advanced cervical spine implant
The FDA has granted SpineFrontier clearance for the Arena-C HA device, an intervertebral body fusion system intended to ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...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
It's better to walk alone than with a crowd going in the wrong direction.
Diane Grant, Canadian playwright and ...Learn More
Maker of Argus II bionic eye targets $31.5M in IPO
Sylmar, Calif.-based Second Sight Medical is looking to obtain $31.5 million with its initial public offering. ...Learn More
Nevro boosts IPO target to $126M
Nevro has increased the amount it hopes to raise in an initial public offering from about $100 million to $126 million. ...Learn More
Hypertension device startup announces $9.7M in funding
Vascular Dynamics, based in the San Francisco Bay Area, has obtained $9.7 million in an equity funding round aiming for ...Learn More
Atlas technology drives Q3 revenue growth for Roka Bioscience
Roka Bioscience generated $1.5 million in revenues during the third quarter, up from $556,000 a year ago. ...Learn More
EU seeks input on safety of medical devices containing plasticizers
The European Commission's Scientific Committee on Emerging Newly Identified Health Risks has issued an updated opinion on ...Learn More
PositiveID partners with military on handheld molecular Dx
PositiveID and the U.S. ...Learn More
ACS guidelines support use of Exact Sciences' colorectal cancer test
Updated guidelines from the American Cancer Society include details on the use of Exact Sciences' Cologuard test for ...Learn More
Cook Medical's Zilver PTX stent shows promise for PAD
The Zilver PTX stent looks promising following a five-year study of 479 patients with peripheral artery disease, according ...Learn More
GOP leaders: Axing device tax is a top priority
Republican leaders in Congress are developing their strategy for attacking the Affordable Care Act. ...Learn More
FDA clears artificial pancreas algorithm for Dexcom device
The FDA has approved Dexcom's Software 505 for its G4 Platinum continuous glucometer. ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...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
Each minute we spend worrying about the future and regretting the past is a minute we miss in our appointment with life.
Thich Nhat Hanh, Vietnamese monk and ...Learn More
Cardio3 to acquire CorQuest Medical
Cardio3 BioSciences has agreed to buy CorQuest Medical, which is working on a tool that gives surgeons direct access to the ...Learn More
AstraZeneca boosts oncology business with Definiens buy
AstraZeneca's MedImmune unit agreed to pay $150 million upfront plus milestone fees to purchase Definiens, a provider of ...Learn More
Push could bring in about $8M for InspireMD's stent systems
Massachusetts-based InspireMD is looking to obtain about $8 million in a direct shares offering. ...Learn More
SV Life Sciences gains majority interest in deal with Ximedica
SV Life Sciences has acquired a majority stake in medtech development firm Ximedica. ...Learn More
Prostate cancer test boosts Q3 revenues for MDxHealth
MDxHealth generated $3.5 million in overall revenues during the third quarter, compared with $2 million in the same period a ...Learn More
Roche announces plans for diagnostics plant in eastern China
Roche has announced plans to establish a plant in eastern China that will be used to manufacture clinical chemistry and ...Learn More
NovioSense wins EU patent for tear glucose monitor
Holland-based NovioSense has secured a patent in Europe for a device that uses a tiny wireless sensor placed in the eye to ...Learn More
Sequent Medical CEO Wilder bets on MicroBraids
Sequent Medical CEO Tom Wilder tells MassDevice.com why his company's MicroBraid technology is a key differentiator in its ...Learn More
S.D. startup behind migraine eyeglass technology gets $1M boost
EyeBrain Medical, a startup based in South Dakota, has obtained $1 million for its NeuroLens technology, which involves ...Learn More
NeoCoil introduces MRI coils for Toshiba scanners
NeoCoil has expanded its MRI coil portfolio with the launch of the 16ch Flex Speeder coils. ...Learn More
Report on device tax's effect is flawed, AdvaMed says
A Congressional Research Service report that suggests the 2.3% medical device tax will have a "relatively small" effect on ...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
The greatest work that kindness does to others is that it makes them kind themselves.
Amelia Earhart, American ...Learn More
Device-tax repeal will be at the top of new Congress' agenda
Though the Affordable Care Act is unlikely to be entirely repealed by the Republican-controlled Congress, the law's tax on ...Learn More
PDI strikes deal to purchase RedPath Integrated Pathology
PDI has agreed to pay $23 million in a cash and stock deal, with a $12 million payment upfront, to purchase RedPath ...Learn More
Growth forecast for orthobiologics in N. America
An analysis by ReportsNReports predicts that the orthobiologics market is poised for growth in North America, driven in part ...Learn More
Kimberly-Clark spins off device unit
Kimberly-Clark has spun off its former Surgical & Infection Prevention and Medical Devices units, creating Halyard Health. ...Learn More
U.K. regulator names former NICE official as chairman
Michael Rawlins has been tapped to serve as chairman of the U.K.'s Medicines and Healthcare Products Regulatory Agency, ...Learn More
Cardiovascular Systems wins approval for PAD device in Europe
A percutaneous orbital atherectomy device developed by Cardiovascular Systems has obtained CE mark approval in Europe. ...Learn More
CDC taps Accelerate Diagnostics for work on biological threat detection
Accelerate Diagnostics is creating rapid pathogen detection assays, including tools for detection of antibiotic resistance, ...Learn More
Portable device helps visualize blood donors' veins
Australian researchers are testing a portable device that can map blood donors' veins using near-infrared light. ...Learn More
Patient input sought on FDA approvals
A notice published Tuesday by the FDA establishes a channel for the public to weigh in on how the agency can incorporate ...Learn More
FDA OKs Covidien's device to treat peripheral artery disease
The FDA has given Covidien 510(k) clearance to market its HawkOne technology, the newest addition to its directional ...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
See AdvaMed-MTLI's schedule of courses
Continue your professional development! See AdvaMed-MTLI's schedule of ...Learn More
People often say that motivation doesn't last. Well, neither does bathing -- that's why we recommend it daily.
Zig Ziglar, American author and motivational ...Learn More
Diagnostics firm LabCorp to acquire Covance for $6.1B
Laboratory Corporation of America, a North Carolina-based company specializing in developing diagnostic tests, announced ...Learn More
Covidien agrees to $30M sale of Stellarex balloon to Spectranetics
Spectranetics will acquire Covidien's Stellarex drug-eluting balloon under a $30 million deal expected to close early next ...Learn More
Spine unit of Integra LifeSciences to become SeaSpine
Integra LifeSciences Holdings, a maker of specialty surgical devices and orthopedic care products, has announced plans to ...Learn More
Maker of bone-graft collection device gets $1M boost
Avitus Orthopaedics has pulled in over $1 million in a funding push that includes a $750,000 grant from the National Science ...Learn More
EU approves Medtronic's advanced drug-eluting stent
European regulators have granted CE Mark approval for Medtronic's Resolute Onyx drug-eluting stent, an advanced version of ...Learn More
Devices will fall under purview of EU's new industry directorate
The European Commission's new industry directorate will assume responsibility for medical device policy in the EU, taking ...Learn More
Hologic scores reimbursement win for 3D mammo device
Procedures using Hologic's 3D mammography technology will receive Medicare coverage under new reimbursement codes released ...Learn More
Advanced ultrasound scanner released by Siemens
The Acuson X600 ultrasound device, designed for cardiology, obstetric and gynecologic diagnostics as well as general ...Learn More
FDA approves AtriCure's DEEP trial for atrial fibrillation
The FDA has given AtriCure an investigational device exemption to conduct a clinical trial for DEEP, which is designed to ...Learn More
Automatic gating tool from Elekta wins FDA nod
The FDA has given Elekta 510(k) clearance to market its Response automatic gating technology for the Clarity 4D prostate ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...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
The most powerful weapon on earth is the human soul on fire.
Ferdinand Foch, French military ...Learn More
IPO could pull in up to $150M for EndoChoice
Georgia-based EndoChoice is looking to obtain as much as $150 million in an initial public offering. ...Learn More
Maker of surgical blood-loss monitoring tool obtains $1.5M
California-based Gauss Surgical has secured $1.5 million by selling equity. ...Learn More
Joint venture aims to improve genetic diagnostics
Baylor College of Medicine has partnered with Tokyo-based Miraca Holdings, a provider of in vitro diagnostics and other ...Learn More
Globus posts positive Q3 results, announces resignation of CFO
Globus Medical reported a 13.5% increase in its third-quarter profit, which was $23.1 million. ...Learn More
Alphatec Spine reports revenue growth in Q3
Alphatec Spine posted consolidated net revenue of $51 million in the third quarter, a 2% increase from a year ago. ...Learn More
Aurora Spine's interspinous fixation implant debuts in Israel
A doctor at the Herzliya Medical Center has performed Israel's first implantation of the ZIP ULTRA minimally invasive ...Learn More
Aesculap advances knee repair tech trial
Aesculap Biologics said its Novocart 3D system has been implanted in the first human patient of its clinical trial. ...Learn More
Partnership aims to tap 3D printing to expedite medtech production
Stratasys, which specializes in 3D printing, is partnering with design firm Worrell on an initiative to use 3D-printed ...Learn More
Prototype takes 1 minute to spot Ebola antibodies
Canada-based bioLytical Laboratories has created a preclinical prototype diagnostic that the company said can detect ...Learn More
U.S., EU regulators OK latest surgical robot from Hansen
The FDA has given Hansen Medical the go-ahead to market the Sensei X2 system, a third-generation version of its surgical ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. -- 2:00 p.m. ...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
Wherever there is a human being, there is an opportunity for a kindness.
Seneca, Roman ...Learn More
Medtronic announces restructuring plans
Medtronic said it plans to reorganize its business into four major operating segments after its merger with Covidien closes, ...Learn More
Zimmer to rebrand after Biomet acquisition
Zimmer announced plans to change its name to Zimmer Biomet upon closing its acquisition of former competitor Biomet. ...Learn More
Rosetta signs molecular Dx distribution deal with Admera
Rosetta Genomics has entered into a distribution deal with Admera Health, a spinoff of GeneWiz, for undisclosed terms. ...Learn More
Smith & Nephew posts 3% revenue increase in Q3
Smith & Nephew reported a 3% increase in its third-quarter revenue to $1.15 billion and a 14% increase in its earnings per ...Learn More
Report: Global orthobiologics market could hit $5.5B by 2019
The worldwide market for orthobiologic devices will increase from $3.7 billion in 2012 to $5.5 billion by the close of ...Learn More
Spartan Bioscience wins Canadian OK for near-patient DNA test
Spartan Bioscience has received the go-ahead in Canada to market the Spartan RX CYP2C19 System for near-patient use. ...Learn More
HTG, Illumina collaborate on in vitro diagnostic test kits
HTG Molecular Diagnostics and Illumina have entered into an agreement to create sequencing-based, in vitro diagnostic kits. ...Learn More
Agfa gains FDA clearance for CR, DR imaging detectors
The FDA has cleared Agfa Healthcare to market its DXD imaging package, which consists of cesium-based image plates and ...Learn More
FDA, Abiomed agree on indication for flagship heart pump
Abiomed expects to receive FDA pre-market approval for its Impella 2.5 heart pump by February or March, following an ...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
I work in whatever medium likes me at the moment.
Marc Chagall, Russian-French ...Learn More
Abbott to acquire 2 catheter-based medical device firms
Abbott has struck a deal to acquire Topera, which develops catheter-based electrophysiology diagnostic technologies, for ...Learn More
Prices of popular medical devices dropped 5% in Aug., index shows
The Modern Healthcare/ECRI Institute technology price index reported a 5% decrease in August in the prices of the top 10 ...Learn More
Zoll Medical agrees to purchase respiratory care device maker
Zoll Medical announced that it has entered an agreement to pay an undisclosed amount to acquire Impact Instrumentation, a ...Learn More
EU approves assay for sexually transmitted infections
European regulators have granted Scienion and Genomica the CE-IVD mark for their Clinical Array Technology STIs A&B, a ...Learn More
Japanese drug firm taps Qiagen in companion Dx deal
A deal reached between Qiagen and Japanese firm Astellas Pharma will focus on the development and commercialization of ...Learn More
Masimo's Kiani on "good-enough innovation," Medtronic, Apple and 25 years of pushing the envelope
MassDevice catches up with Masimo CEO Joe Kiani to discuss new challenges facing the company and how medtech can break the ...Learn More
Scientists develop blood test for Alzheimer's disease
Australian researchers have developed a blood test that is 91% accurate in detecting Alzheimer's disease years before ...Learn More
Yale, OPM to collaborate on 3D-printed biomedical devices
Yale University has agreed to work with Oxford Performance Materials on 10 projects to study the application of 3D printing ...Learn More
PENTAX announces U.S., Canadian launch of advanced GI endoscope
PENTAX is making its i10 Series HD+ endoscope, which gives doctors a high-definition view of the upper gastrointestinal ...Learn More
Biological Signal's heart attack Dx device OK'd by FDA
The FDA has granted Biological Signal Processing the green light to market a device that uses an ECG at rest to allow more ...Learn More
FDA grants compassionate use provision for Aethlon's Ebola treatment device
Aethlon Medical has received approval to provide its blood-filtration device, the Hemopurifier, as an Ebola treatment under ...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
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
The measure of who we are is what we do with what we have.
Vince Lombardi, American football ...Learn More
VC firm to invest $235M in medical device, drug companies
Advent Life Sciences has secured an investment fund worth $235 million, which it will pump into medical device and ...Learn More
Leica Biosystems acquires breast biopsy tech developer
Leica Biosystems, a unit of Danaher, has agreed to pay an undisclosed sum to acquire breast biopsy device firm Devicor ...Learn More
Stock sale could bring in net proceeds of $18.4M for Nanosphere
Nanosphere has completed its public shares offering, which the company said could bring in about $18.4 million in net ...Learn More
Roche unit signs companion Dx deal with ImmunoGen
Ventana Medical Systems, a Roche unit, has agreed to work with ImmunoGen to create an immunohistochemistry-based test that ...Learn More
Recent acquisitions drive Q3 revenue growth for LabCorp
Laboratory Corp. of America reported a 6.1% increase in revenue during the third quarter. ...Learn More
Report: Global bio-implants market could hit $115.8B in 6 years
A report from Allied Market Research predicts that by 2020, the worldwide market for bio-implants could be worth $115.8 ...Learn More
Trial underway for Medtronic's heart valve implant
A patient at a hospital in Ohio has become the first to be implanted with Medtronic's heart valve replacement device as part ...Learn More
Nanoscale device monitors effect of cancer drug in the blood
A new nanoscale device developed by scientists at the University of Montreal can monitor concentrations of methotrexate in ...Learn More
FDA clears shoulder fixation device from Dallen Medical
The FDA has cleared Dallen Medical to market the Tensyn Band, designed to repair the coracoacromial ligament and ...Learn More
Upgraded radiotherapy planning tool from RaySearch wins FDA nod
Version 4.5 of RaySearch Laboratories' RayStation radiotherapy planning technology has obtained 510(k) clearance from the ...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
The great geniuses are those who have kept their childlike spirit and have added to it breadth of vision and experience.
Alfred Stieglitz, American ...Learn More
Wright Medical and Tornier to combine in stock-for-stock deal
A merger has been announced between Wright Medical Group and Dutch company Tornier, with each Wright Medical share to be ...Learn More
Globus Medical buys Texas bone allograft maker
Transplant Technologies of Texas, a distributor of bone allografts, biomaterials and soft tissue products, has been acquired ...Learn More
Integra wraps up purchase of Medtronic's ENT instrument lines
Integra LifeSciences' purchase of Medtronic's Xomed and MicroFrance lines of ear, nose, throat and laparoscopic instruments ...Learn More
Hospital GPO awards imaging device contract to Infraredx
HealthTrust Purchasing Group, a hospital group purchasing organization, has awarded a supply contract to Infraredx. ...Learn More
Zyga wins CE mark approval for Glyder Facet Restoration Device
Zyga Technology has earned the CE mark for its Glyder Facet Restoration Device, which offers release from lumbar facet pain. ...Learn More
Cadens Medical enters partnership with Hisense Medical
Cadens Medical Imaging of Canada has struck a multimillion-dollar deal with Hisense Medical, a Chinese multinational ...Learn More
Chembio, IBT to collaborate on point-of-care Ebola tests
Chembio Diagnostics has entered into a partnership with Integrated BioTherapeutics, for an undisclosed amount, to develop ...Learn More
Advanced lung imaging tech introduced by Covidien
An upgraded version of the superDimension electromagnetic navigation bronchoscope, designed for pulmonary imaging ...Learn More
St. Jude wins FDA nod for TactiCath Quartz ablation catheter
The FDA has granted St. Jude Medical approval to market its TactiCath Quartz irrigated ablation catheter. ...Learn More
Covidien unit gains wider FDA OK for peripheral stent
Ev3, a unit of Covidien, has obtained expanded FDA approval for use of its EverFlex peripheral stent in treating patients ...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
Never, 'for the sake of peace and quiet,' deny your own experience or convictions.
Dag Hammarskjold, Swedish ...Learn More
Device tax, approval delays cause more U.S. firms to go offshore, AdvaMed CEO says
The medical device tax and FDA approval delays remain major factors influencing an increasing number of companies to launch ...Learn More
Medtronic to use $16B in assumed debt to pursue Covidien deal
Medtronic will help finance its purchase of Covidien for $43 billion by assuming U.S. ...Learn More
Aurora Spine signs marketing deal with MedAssets
Aurora Spine has agreed to give MedAssets' network of hospitals and health care providers access to its product line under a ...Learn More
Edwards Lifesciences beats Q3 earnings estimates
Edwards Lifesciences reported a 23% increase in sales and a 14% increase in earnings compared to last year's third quarter. ...Learn More
Maker of GERD device cancels plans to go public
Renaissance Capital said EndoStim has called off its previously announced plans to launch an initial public offering aimed ...Learn More
EU approves Amoy Diagnostics' cancer mutation assays
China-based Amoy Diagnostics has obtained the CE mark for its cancer mutation assays for NRAS, KRAS/NRAS, RET and ERCC1. ...Learn More
Myriad creates European lab to offer tumor diagnostic
Myriad Genetics has set up a laboratory in Munich, Germany, to provide the company's Tumor BRACAnalysis CDx assay across ...Learn More
Rapid test predicts risk of developing severe sepsis
Canadian researchers have created a test that can quickly assess the risk that patients will develop severe sepsis. ...Learn More
U.S., EU regulators OK ambulatory infusion pump from Zyno
The FDA has cleared Zyno Medical to market its Nimbus Ambulatory Infusion Pump, which the company said can be used to ...Learn More
FDA authorizes emergency use of BioFire's Ebola tests
The FDA has authorized emergency use of two new Ebola tests developed by BioFire Defense in U.S. hospitals. ...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
The real art of conversation is not only to say the right thing in the right place but to leave unsaid the wrong thing at the tempting moment.
Lady Dorothy Nevill, British ...Learn More
OxySure, Estill Medical sign merger deal
OxySure has entered into a merger deal with Estill Medical Technologies, whose products include the Thermal Angel system ...Learn More
Investors pump $5.5M into hypertension device startup
Sympara Medical has received $5.5 million in funding from a small group of investors, the firm revealed in a regulatory ...Learn More
Calif. blood cancer test startup lands investment from Celgene
Sequenta has received an undisclosed investment from Celgene, which the California-based startup will use to help launch ...Learn More
Quest Diagnostics reports Q3 revenue growth
Quest Diagnostics generated $1.9 billion in revenues during the third quarter, compared with $1.79 billion during the same ...Learn More
Former Mayo Clinic exec named to RTI Surgical's board
Shirley Weis, the president of Weis Associates, has been tapped to serve on the board of directors at RTI Surgical. ...Learn More
Akers Biosciences forms joint venture with Chinese company
Akers Biosciences has formed a joint venture with Hainan Savy Investment Management that will focus on distributing Akers' ...Learn More
Biotech startups, government work on brain stimulus devices
Silicon Valley startups are following the lead of government researchers to determine whether electrical stimulation from ...Learn More
Crossing catheter from ReFlow wins FDA nod
The FDA has cleared ReFlow Medical to market its Wingman35 crossing catheter, which the company said is already available in ...Learn More
Study finds improvements in FDA's device-review programs
The FDA took an average of 297 days to approve high-risk medical devices under the premarket approval application program in ...Learn More
FDA OKs study of Gynesonics' uterine fibroid technology
The FDA has granted Gynesonics an investigational device exemption for a pilot study of its VizAblate technology, which ...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
Happiness is like a butterfly: the more you chase it, the more it will elude you, but if you turn your attention to other things, it will come and sit softly on your shoulder.
Henry David Thoreau, American writer and ...Learn More
Boston Scientific's spinal surgical leads win U.S., EU approval
European regulators have granted Boston Scientific the CE mark for its CoverEdge 32 and CoverEdge X 32 spinal surgical ...Learn More
Medtronic affirms intent to consummate $43B Covidien deal
Medtronic has affirmed its plans to acquire Covidien for $43 billion, saying the deal could be finalized late this year or ...Learn More
Sorin makes $20M investment in Respicardia
Minnesota-based startup Respicardia, which is working on an implantable system used to treat central sleep apnea, has ...Learn More
Investors pump $13M into Calif. molecular Dx company
California-based InSilixa has obtained $13 million in financing from Morningside and PointGuard Ventures. ...Learn More
Heart device sales boost Q3 revenue, profit for Boston Scientific
Boston Scientific reported a 6% increase in revenue and $43 million in net income during the third quarter. ...Learn More
Enigma moves to bring molecular Dx platform to China
Enigma Diagnostics has entered into a joint venture with Beijing Leadman Biochemistry to offer the Enigma Mini Laboratory ...Learn More
5 factors affecting the future of medtech
These five factors will determine the future of the medical device industry. Read the ...Learn More
Exact Sciences' colorectal cancer test to be offered by MDVIP
MDVIP has agreed to offer Exact Sciences' ColoGuard test to its network of primary care doctors across the U.S. ...Learn More
Breath-based test can rapidly detect hospital-acquired infections
Isomark has designed a new type of breathalyzer that can spot hospital-acquired infections within two hours of onset. ...Learn More
FDA clears bioceramic burr hole plug from OssDesign
The FDA has given 510(k) clearance for Sweden-based OssDesign's Cranioplug, a bioceramic bone implant intended to be used in ...Learn More
New patent issued to Expanding Orthopedics
Expanding Orthopedics has been issued a patent covering vertebral compression fracture technologies and expandable interbody ...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
For the past 33 years, I have looked in the mirror every morning and asked myself: 'If today were the last day of my life, would I want to do what I am about to do today?' And whenever the answer has been ...
Steve Jobs, American ...Learn More
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
Follow AdvaMed on Google+
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
Follow AdvaMed on Google+
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


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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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