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FDA proposes device user fee reductions for FY 2015
The FDA's device center has issued a proposal to lower the medical device user fees for fiscal year 2015 by 3% across the ...Learn More
Report: X-ray market in U.S. could be worth $1.1B in 6 years
A GlobalData report forecasts that the U.S. ...Learn More
Blood pressure assets of Centron purchased by SunTech Medical
Blood pressure management firm SunTech Medical has agreed to pay an undisclosed sum to acquire the assets of Centron ...Learn More
Epic Sciences to advance cancer test with $30M in fresh capital
Epic Sciences has obtained $30 million in Series C financing, which CEO Murali Prahalad said will be used to bring the ...Learn More
EU adopts hazardous material restrictions for medical devices
The European Commission has adopted new rules mandating that all medical devices, except active implants, satisfy the ...Learn More
Report forecasts growth for global trauma fixation device market
A Transparency Market Research report predicts that the worldwide market for orthopedic trauma fixation systems could be ...Learn More
Calhoun Vision tackles the "Holy Grail" of ophthalmology with new lens
For years, the "Holy Grail" of ophthalmology has been to give patients the ability to see clearly in both near and far ...Learn More
Invitae enters genetic cancer test partnership with Nanopharmacia
Invitae will make its genetic assays for hereditary cancers available in Mexico under a deal reached with Nanopharmacia. ...Learn More
Glide Pharma gains rights to FScan's prostate cancer Dx technology
Glide Pharmaceutical Technologies was granted exclusive licensing rights to a prostate cancer diagnostic technology ...Learn More
Technology allows accurate detection of secondary cataracts
Spanish researchers have created a fully automatic tool that they say can detect posterior capsule opacity, or secondary ...Learn More
Proposed Mass. tax credit would offset 2.3% device tax
The fiscal 2015 budget approved by Massachusetts Gov. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Against the assault of laughter nothing can stand.
Mark Twain, American ...Learn More
Final rule prohibits "split predicates" under 510(k) process
The FDA has released a final rule disallowing use of "split predicates" under the agency's 510(k) clearance program. ...Learn More
Investors pump $172M into smart pill tech developer
Proteus Digital Health, which has developed a smart pill system with embedded sensors that link to a skin patch, has secured ...Learn More
Maker of smartphone-based vision testing device obtains $4M
A Series A funding round has pulled in $4 million for EyeNetra, the maker of a smartphone-based device that can be used to ...Learn More
Sequenom signs licensing deal with Mayo, posts Q2 revenue growth
Sequenom has agreed to license patents and applications related to its noninvasive prenatal tests to Mayo Medical ...Learn More
Medtronic strikes pacemaker manufacturing deal in China
Lifetech Scientific will work with Medtronic to manufacture pacemakers under an expanded deal reached between the companies. ...Learn More
AstraZeneca signs companion diagnostic deals with Roche, Qiagen
AstraZeneca has tapped Roche Holding and Qiagen to develop separate blood-based tests that can be used as companion ...Learn More
New device uses microscopic laser beams to draw blood
Scientists at NoNeedles Venipuncture are developing a new process that uses laser pulses instead of a needle to draw blood. ...Learn More
Intellijoint gains FDA OK for smart tool used during hip surgery
The FDA has cleared Intellijoint Surgical to market a smart tool designed to aid surgeons when performing hip replacement ...Learn More
Gonorrhea, chlamydia tests from Becton Dickinson win FDA nod
BD Diagnostics has received FDA clearance for a pair of tests used to detect gonococcal urogenital disease and chlamydia in ...Learn More
FDA OK for lung infection device sought by Asthma & Allergy
Asthma & Allergy Prevention Co. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
To invent, you need a good imagination and a pile of junk.
Thomas Edison, American ...Learn More
Medtech firms paid $1.4B in excise taxes in 2013, IRS data show
Data from the Internal Revenue Service indicate that medtech firms made excise tax payments of $1.4 billion last year when ...Learn More
Medtronic to pay up to $105M for laser ablation device firm
Medtronic has agreed to acquire Visualase, the maker of an MRI-guided laser ablation system used during minimally invasive ...Learn More
T2 Biosystems amends IPO target to as much as $65.9M
An initial public offering earlier announced by T2 Biosystems could bring in as much as $65.9 million in net proceeds, ...Learn More
Augmenix hopes to advance surgical hydrogel with $10.8M in financing
Augmenix has raised $10.8 million in Series D financing, which the Massachusetts-based company aims to use to support its ...Learn More
HealthTrust signs molecular Dx supply deal with BioFire
HealthTrust has tapped BioFire Diagnostics to supply its provider network with the company's multitarget molecular ...Learn More
Outgoing CFO of Covidien named to Haemonetics board
Charles Dockendorff has been appointed to serve on the board of directors at Haemonetics. ...Learn More
New GMP rules for medical devices proposed in S. Korea
The Ministry of Food and Drug Safety in South Korea has issued a proposal amending its good manufacturing practice rules for ...Learn More
Mainstay gets green light to expand ReActiv8 trial in U.K.
U.K. regulators have given Mainstay Medical the go-ahead to add U.K. ...Learn More
Advanced cervical-disk implant from Medtronic wins FDA nod
Medtronic has won FDA approval to market an updated version of its Prestige cervical-disk implant launched in 2007. ...Learn More
Quidel's Group A strep test lands FDA clearance
Quidel has received clearance from the FDA to market its AmpliVue GAS Assay. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
We must open the doors of opportunity. But we must also equip our people to walk through those doors.
Lyndon B. Johnson, 36th U.S. ...Learn More
Sorin's next-gen heart valve wins approval in Europe
Sorin has earned the CE mark in Europe for its Crown PRT, a next-generation device used to treat patients with aortic valve ...Learn More
Cardiovascular molecular Dx firm advances $25M funding round
A regulatory filing disclosed that CardioDx has obtained $21 million in a funding round aiming for $25 million. ...Learn More
Funding round brings in $6M for CyMedica Orthopedics
CyMedica Orthopedics has pulled in $6 million in a financing round, according to a regulatory filing. ...Learn More
Minn. surgical-waste-management firm obtains funds
Skyline Medical, which specializes in surgical-waste management, has received from two undisclosed backers more than ...Learn More
Surgical-implant business helps boost Q2 sales for DJO Global
DJO Global posted $313.9 million in net sales during the second quarter, a 6.5% increase over the same period in 2013. ...Learn More
Canadian hospital gets $1.4M boost to build molecular oncology lab
The Ottawa Hospital is set to establish a molecular oncology diagnostic facility using $1.4 million in financing. ...Learn More
Ohio hospital first to use Aurora's bone allograft in U.S.
A doctor at Madison County Hospital in Ohio has performed the first U.S. ...Learn More
Qiagen gains license for potential blood cancer biomarkers
Qiagen has licensed four biomarkers from the University of Tokyo that can be used for assessing treatment prognosis in blood ...Learn More
MIT-developed test offers cheaper, easier way to detect cancer
A professor at the Massachusetts Institute of Technology has created an assay that can be used to detect cancer with the ...Learn More
Medtronic agrees to pay $2.8M to settle insulin pump lawsuit
Medtronic has reached a $2.8 million settlement deal with the federal government and 36 states to resolve a lawsuit accusing ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
There is no disguise which can hide love for long where it exists, or simulate it where it does not.
Francois de La Rochefoucauld, French ...Learn More
Boston Scientific's drug-coated balloon wins EU approval
Regulators in Europe have granted the CE mark to Boston Scientific's Agent balloon catheter, designed to treat patients with ...Learn More
Pa. cardiovascular device firm lands $3.85M investment
Pennsylvania-based Intelomed, the maker of a noninvasive tool for real-time detection of a patient's risk for cardiovascular ...Learn More
3 medtech startups receive $100K each in Md. innovation awards
Three startups developing medical technologies won investments worth $100,000 each from the Maryland Innovation Initiative. ...Learn More
Illumigene products help fuel FY Q3 sales growth for Meridian
Meridian Bioscience generated $47.2 million in sales during the company's fiscal year 2014 third quarter, up from $47.1 ...Learn More
Millstone Medical to expand facility, workforce in Mass.
Millstone Medical Outsourcing has announced plans to add 40,000 square feet to its existing medical-device packaging and ...Learn More
Elekta hopes to expand footprint in Turkey with Mesi Medikal buy
Elekta has agreed to acquire Mesi Medikal, a distributor of radiation therapy devices in Turkey, for undisclosed terms. ...Learn More
Grifols gets CE mark for hepatitis E detection test
Grifols has earned the CE mark in Europe for the Procleix HEV test, which it developed with Hologic. ...Learn More
Study of staph infections on implanted devices wins $10M grant
A University of Nebraska Medical Center study of antibiotic-resistant infections related to implanted devices has won a $10 ...Learn More
Philips' mobile ultrasound scanner scores FDA clearance
The FDA has cleared Philips Healthcare to market its Visiq system, a mobile ultrasound scanner designed to ease the way ...Learn More
FDA OKs Spectranetics' devices to treat in-stent restenosis
Spectranetics has received 510(k) clearance from the FDA for its Turbo Elite and Turbo-Tandem peripheral atherectomy ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The important thing in life is not to have a good hand but to play it well.
Louis Fortin, ...Learn More
Teleflex's chronic hemodialysis catheter wins FDA nod
The FDA has cleared Teleflex to market its Arrow-Clark VectorFlow catheter, designed for use in patients undergoing chronic ...Learn More
Infectious-disease-product sales boost Q2 revenue for Quidel
Quidel posted $31.5 million in revenue during the second quarter, up from $29.7 million during the same period last year. ...Learn More
Connecticut Innovations awards $10K each to 2 medtech startups
Vesselon and 109 Design were among five startups in Connecticut that won $10,000 each through Connecticut Innovations' ...Learn More
ConMed picks former Stryker exec to serve as interim CEO
Former Stryker Chief Financial Officer and interim CEO Curt Hartman has been tapped to serve as interim CEO of ConMed. ...Learn More
New medtech classification system proposed in Russia
Regulators in Russia have proposed a new system to classify medical devices in that country based on the Global Medical ...Learn More
IMRIS' surgical theater with advanced MRI feature gains CE mark
IMRIS has won CE mark approval in Europe to market its Visius Surgical Theatre, which features a next-generation version of ...Learn More
Podcast: CEO Brian Concannon on the past and future for Haemonetics
Haemonetics CEO Brian Concannon discusses how the company will transform blood management in the coming years at ...Learn More
NeuroPace partners with DARPA on memory-loss study
The Defense Advanced Research Projects Agency has tapped NeuroPace to investigate the use of implantable neurostimulators to ...Learn More
Lung cancer study to use Foundation Medicine's assay
The Bonnie J. ...Learn More
Breast density software from VuCOMP cleared in Canada
VuCOMP has received the green light to market its M-Vu Breast Density technology in Canada. ...Learn More
Proposed Sunshine regulations could mean new costs for medtech firms
Experts have voiced concerns that proposed changes to the Physician Payments Sunshine Act, which requires health care firms ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Progress begins with the belief that what is necessary is possible.
Norman Cousins, American ...Learn More
St. Jude earns CE mark for next-gen heart ablation device
St. ...Learn More
J&J's $5B share repurchase program wins board approval
A plan by Johnson & Johnson to buy back as much as $5 billion of its stock has been approved by the company's board. ...Learn More
First tranche of Trice Medical's $11.6M funding round completed
Trice Medical has completed the first part of its Series B funding round aiming for $11.6 million. ...Learn More
Mass. miRNA assay firm advances $1.5M funding round
A funding round aiming for $1.5 million has brought in $775,000 for Firefly BioWorks. ...Learn More
Hanson tapped to serve as group president at Covidien
Bryan Hanson, president of Covidien's medical device unit, has been appointed to serve as the company's group president. ...Learn More
Comments sought on EU proposal to evaluate nano-based devices
The European Commission has released preliminary guidelines governing the risk assessment of medical devices that use ...Learn More
Company developing point-of-care Dx test gets $2.5M boost
SenGenix, a Duke University spinoff, has received $2.5 million from investors. ...Learn More
N.Y. grants final approval for Rosetta's kidney cancer test
The Department of Health in New York state has given Rosetta Genomics final approval to offer its kidney cancer test in the ...Learn More
Advanced intravascular ultrasound introduced by Boston Scientific
Boston Scientific has expanded its intravascular ultrasound product line with the release of its Polaris system. ...Learn More
FDA gives green light to Veniti's venous stent trial
The FDA has granted Veniti investigational device exemption to conduct a clinical study of its Vici Venous Stent System, ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
The young do not know enough to be prudent and therefore they attempt the impossible -- and achieve it, generation after generation.
Pearl S. Buck, American ...Learn More
Boston Scientific gets FDA green light for bare-metal stent
The FDA has granted Boston Scientific approval to market a bare-metal stent built out of the same architecture and platinum ...Learn More
Illumina receives $1.5M in tax breaks in San Diego
San Diego has agreed to provide Illumina with tax incentives worth $1.5 million over a period of 10 years, keeping the ...Learn More
Firms jointly develop next-generation sequencing tech
Illumina and Berry Genomics have created a next-generation sequencing tool that combines Berry's Bambni noninvasive prenatal ...Learn More
Pain management device firm gets new CFO
Brian Alleman has been appointed to replace Anthony Scalese as chief financial officer of Zynex, a maker of noninvasive ...Learn More
New U.K. committee aims to improve access to medtech specialist advice
The U.K. ...Learn More
Companies in Italy must register certain IVD medical devices in national database
New rules require IVD companies operating in Italy to register their products in the Repertorio national database of medical ...Learn More
Study of Medrobotics' surgical robot kicks off in Germany
Doctors at a hospital in Germany were the first to use Medrobotics' Flex surgical robot to successfully remove cancerous ...Learn More
ConforMIS' device fares better than standard implants in TKA study
A clinical study found that patients treated with the ConforMIS iTotal personalized knee implant had lower hospital costs, ...Learn More
Soft-tissue transponder from Varian Medical wins FDA nod
Varian Medical Systems has been cleared by the FDA to market its Calypso Beacon transponder, which the company said can be ...Learn More
Sunshine Act disclosure website marred by glitches, reports say
Early reports show some glitches with the Open Payments website, the federal database designed to show doctor payments from ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Too often we enjoy the comfort of opinion without the discomfort of thought.
John F. Kennedy, 35th U.S. ...Learn More
Cost of disease is countered by medtech benefits, study finds
The benefits of medical technology contribute a net added benefit of $23 billion per year, according to a report published ...Learn More
For more:
Read the AdvaMed press release with President and CEO Stephen Ubl's comments commending the findings of the Milken Institute ...Learn More
Bausch + Lomb gains FDA OK for cataract surgery device
The FDA has given Bausch + Lomb 510(k) clearance to market its VICTUS femtosecond laser system. ...Learn More
Thermo Fisher agrees to $480M sale of laboratory unit
Thermo Fisher Scientific has struck a deal to sell its Cole-Parmer laboratory equipment business to GTCR, a private equity ...Learn More
Arup Laboratories to distribute HIV test across U.S.
Arup Laboratories has agreed to market nationwide an HIV assay developed at University Hospitals Case Medical Center. ...Learn More
Rules governing medtech studies, registrations issued in India
Regulators in India have released guidelines explaining the requirements for registering medical devices and conducting ...Learn More
Mazor's surgical robot shows efficacy in scoliosis trial
A clinical study found that surgeons who used Mazor Robotics' Renaissance system positioned pedicle screws in adolescent ...Learn More
N.Y. approves institute's cancer molecular Dx test
The Department of Health in New York state has authorized the Roswell Park Cancer Institute to use OmniSeq Target assay in ...Learn More
Next-gen bone graft from Synergy gets wider FDA OK
Synergy Biomedical has been cleared by the FDA to expand the use of its BioSphere Putty, a next-generation bone graft that ...Learn More
FDA creates educational program to spur medtech development
The FDA has developed a program to educate students and entrepreneurs about the agency's process for evaluating medical ...Learn More
FDA expands clearance for Blue Belt's surgical device
The FDA has granted Blue Belt Technologies expanded clearance for its Navio surgical system to be used during patellofemoral ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
I give myself sometimes admirable advice, but I am incapable of taking it.
Mary Wortley Montagu, British ...Learn More
Danaher unit to acquire Siemens' clinical microbiology division
Beckman Coulter, a unit of Danaher, has agreed to pay an undisclosed sum to acquire the clinical microbiology business of ...Learn More
Lantheus' planned IPO could bring in up to $139M
Massachusetts-based Lantheus Medical Imaging said it could pull in up to $139 million from its planned initial public ...Learn More
N.J. molecular Dx firm eyes $60M from IPO
New Jersey-based Roka Bioscience looks to obtain $60 million in an initial public offering. ...Learn More
Clinical molecular biology sales boost revenue growth for bioMerieux
BioMerieux posted net sales of $1.06 billion during the first half of this year, up almost 4% from the same period last ...Learn More
EU grants CE mark for Biotronik's MRI-safe defibrillators
Biotronik has earned the CE mark in Europe for its Inventra line of implantable cardiac resynchronization therapy ...Learn More
Report: Global surgical navigation tech market poised for growth
A report from Transparency Market Research predicts that the worldwide market for surgical navigation tools could increase ...Learn More
Foundation awards $4.7M for prostate cancer test development
The Movember Foundation has awarded $4.7 million to a team of Canadian scientists to support the development of molecular ...Learn More
Longitudinal Prize offers $17.1M for point-of-care bacterial infection test
The Nesta Foundation, the Technology Strategy Board of the U.K. and the British Broadcasting Corp. ...Learn More
Knee arthroplasty technology unveiled by Exactech
The Optetrak Logic Porous technology, which features an advanced implant coating, has been introduced by Exactech. ...Learn More
Obama administration urged to block FDA's plan to regulate LDTs
A group of laboratory directors has called on the Obama administration to prevent the FDA from regulating ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Most of us spend too much time on what is urgent and not enough time on what is important.
Stephen Covey, American writer and ...Learn More
SynCardia gains FDA OK for portable artificial heart driver
The FDA has granted SynCardia Systems approval to market the Freedom driver for use with the company's Total Artificial ...Learn More
Group looks to invest up to $60M in life sciences startups
A fund worth as much as $60 million is being raised by the New York City Economic Development Corp. ...Learn More
Illumina buys companion Dx consulting firm
Illumina has agreed to pay an undisclosed sum to purchase Myraqa, which provides regulatory and quality consulting services ...Learn More
Medbio breaks ground on $3.39M facility expansion in Mich.
Medbio has initiated a project to expand its production and warehouse facility in Cascade Township, Mich. ...Learn More
Report: Global medical polymer market could hit $7.05B by 2020
The growing use of high performance polymers to replace metal and glass in medical devices could help the worldwide medical ...Learn More
Podcast: Medical device execs discuss M&A activity
MassDevice.com speaks to 3M's Deb Rectenwald, St. ...Learn More
BioTheranostics gets OK to distribute breast cancer Dx in N.Y.
BioTheranostics has received the go-ahead to distribute its Breast Cancer Index in New York. ...Learn More
Covidien's soft tissue ablation device could hit market in Q3
Covidien said its Emprint system, which was cleared by the FDA in April, could be available commercially in the third ...Learn More
Cartilage allograft kit from RTI debuts at conference
A device used for osteochondral allograft resurfacing was introduced by RTI Surgical at a recent sports medicine conference ...Learn More
DorsaVi's activity-monitoring device lands FDA clearance
The FDA has cleared dorsaVi to market its ViMove system for use in clinical settings or athletic training. ...Learn More
FDA clears IBA's compact gantry for proton therapy device
Ion Beam Applications has been cleared by the FDA to market its Compact Gantry Beam Line, which will be integrated with the ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Be brave enough to start a conversation that matters.
Margaret Wheatley, American ...Learn More
Boston Scientific's 25 mm heart valve clears EU hurdle
European regulators have granted Boston Scientific CE mark approval to sell a 25-millimeter model of its Lotus transcatheter ...Learn More
Mass. startup behind vascular sleeve tech gets $11M boost
A round of financing from six undisclosed backers has pulled in $11 million for Massachusetts-based Neograft. ...Learn More
Calif. glucose device company advances $5.1M funding round
Metronom Health has secured $4.8 million in a financing round aiming for $5.1 million. ...Learn More
N.Y. grants conditional OK for CombiMatrix's pediatric disorder test
The New York State Department of Health has given CombiMatrix conditional approval to distribute its CombiSNP test for ...Learn More
Transplant Genomics secures license to patents related to transplant diagnostics
Transplant Genomics has gained an exclusive license to patent rights on technology from The Scripps Research Institute and ...Learn More
Mexico approves Guided Therapeutics' cervical scanning device
Guided Therapeutics has received the go-ahead in Mexico to market its LuViva Advanced Cervical Scan, a noninvasive scanning ...Learn More
Canadian molecular Dx firm obtains $23.8M in Series B financing
Xagenic, whose flagship product is the Amplified Redox Assay that can quickly detect nucleic acids in clinical samples ...Learn More
Novartis, Google partner on contact lenses to track blood glucose levels
Novartis and Google are partnering on "smart" contact lenses that could track diabetics' blood glucose levels. ...Learn More
Device shows promise for early detection of Alzheimer's
A device being commercialized by NeuroVision Imaging has been shown in a 40-patient study to have the ability to accurately ...Learn More
FDA OKs Dallen's disposable small-bone fixation device
The FDA has cleared a disposable model of Dallen Medical's Compressyn Staple Delivery System. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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
I never dreamed about success. I worked for it.
Estee Lauder, American ...Learn More
St. Jude strikes deal to acquire NeuroTherm for $200M
St. ...Learn More
N.C. cancer Dx firm secures $5M in financing
A regulatory filing disclosed that GeneCentric Diagnostics has obtained $5 million in a funding round. ...Learn More
Miacom signs pathogen Dx distribution deal with Fosun
China-based Fosun Diagnostics has agreed to distribute Miacom Diagnostics' proprietary multiplex tests in Asia. ...Learn More
Intact picks former Neuronetics exec as president and CEO
Intact Vascular has appointed Bruce Shook to serve as its new president and CEO, replacing Carol Burns. ...Learn More
Boston Scientific's drug-eluting balloon gets CE mark
Boston Scientific has received CE mark approval to market its Ranger device in Europe. ...Learn More
"Swimmable" hearing implant gains approval in China
Chinese regulators have granted Advanced Bionics the green light to market its Neptune cochlear implant for use by patients ...Learn More
C2N gains global commercial rights for Alzheimer's assay
The Washington University School of Medicine has granted C2N Diagnostics exclusive rights to market worldwide a clinical ...Learn More
Mitek launches platelet-rich-plasma device
Mitek Sports Medicine has released a lightweight device that can isolate platelet-rich-plasma from the patient's blood. ...Learn More
510(k) risk-benefit review proposal issued by FDA
Draft guidance released by the FDA outlines how the agency evaluates the risks and benefits of medical devices submitted ...Learn More
Lateral fusion device from Titan Spine receives FDA OK
Titan Spine's Endoskeleton TL device, designed for lateral spinal fusion surgery, has been cleared by the FDA. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
No person was ever honored for what he received. Honor has been the reward for what he gave.
Calvin Coolidge, 30th U.S. ...Learn More
Eye device firm targets as much as $80M from IPO
Massachusetts-based Ocular Therapeutix said it will launch an initial public offering in hopes of obtaining up to $80 ...Learn More
N.Y. cancer Dx firm receives $1M funding boost
Empire Genomics, which specializes in cancer diagnostics, has raised $1 million in a recent funding round. ...Learn More
Integra increases credit facility to $900M
Integra LifeSciences has raised its credit facility to $900 million, which will be due July 2, 2019. ...Learn More
Former Medtronic exec to take the helm of CryoLife
James Patrick Mackin, a former executive at Medtronic, has been appointed to serve as president and CEO of CryoLife ...Learn More
Aging population predicted to drive global ultrasound market growth
A Transparency Market Research report projects that the worldwide ultrasound device market could be valued at $8.7 billion ...Learn More
EU grants CE mark for Natera's cloud-based tool
Natera has won CE mark approval to market its cloud-based technology in Europe. ...Learn More
Study shows promising results for Abbott's MitraClip device
A clinical study found that 84% of patients saw reduced mitral regurgitation, improved quality of life and decreased ...Learn More
Quantel Medical lands FDA clearance for Optimis Fusion platform
Quantel Medical garnered FDA approval for its Optimis Fusion ophthalmic laser platform for the treatment of cataracts and ...Learn More
List of recognized medtech standards updated by FDA
The FDA has updated its list of recognized standards for premarket evaluation of medical devices to include 33 new entries, ...Learn More
FDA authorizes Qubyx to sell imaging tech package
The FDA has cleared Qubyx to market the Dell UltraSharp U3014 display in combination with the Qubyx PerfectLum DICOM ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
There's a great power in words, if you don't hitch too many of them together.
Josh Billings, American ...Learn More
VCs backed $2.7B in health care deals in Q2
Venture capitalists invested about $2.7 billion in 161 health care deals in the second quarter, according to CB Insights' ...Learn More
ReShape raises $4M to pursue FDA OK for obesity device
A regulatory filing disclosed that ReShape Medical has secured $4 million in a debt funding round. ...Learn More
Calif. cryoablation-device firm advances $12M financing round
A Series B funding round aiming for $12 million has pulled in $500,000 for CryoMedix. ...Learn More
PPO awards cancer Dx contract to bioTheranostics
FedMed, a Maryland-based preferred provider organization, has awarded a contract to bioTheranostics. ...Learn More
EU OKs interbody fusion device from Expanding Orthopedics
Expanding Orthopedics has earned the CE mark in Europe for its FLXfit system, a 3D expandable cage used during minimally ...Learn More
Ventana, Merck sign companion Dx development deal
Merck KGaA has tapped Ventana Medical Systems to create and validate a companion diagnostic assay that will be used for ...Learn More
Konica to equip scanner with ultrasound training package
Konica Minolta Medical Imaging said it will integrate its Sonimage P3 handheld scanner with SonoSim's ultrasound training ...Learn More
Microarray test designed to ID cause of multiple miscarriages
A microarray test meant to help identify the exact reason for multiple miscarriages has been developed by CombiMatrix. ...Learn More
FDA allows Cook Medical's Evolution devices to re-enter market
The FDA has permitted Cook Medical to resume U.S. ...Learn More
Medicare coverage for melanoma device sought by Mela Sciences
Mela Sciences has submitted documents to earn a Medicare Part B reimbursement code for its MelaFind system, a handheld ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
If once you forfeit the confidence of your fellow citizens, you can never regain their respect and esteem.
Abraham Lincoln, 16th U.S. ...Learn More
Merit unit gains OK for tracheobronchial stent in China
Merit Medical subsidiary Endotek has received the green light to market its Aero tracheobronchial stent, along with the ...Learn More
Calif. heart failure device firm gets $12.4M boost
California-based BioVentrix has raised $12.4 million in a round of financing from 195 undisclosed backers. ...Learn More
Cardiac Insight obtains $7M in funding round
A funding round has pulled in $7 million for Cardiac Insight, a spinoff of the University of Washington. ...Learn More
Maker of uterine fibroid device gains $6.3M in fresh capital
A group of 16 undisclosed backers has pumped $6.3 million into Gynesonics, the maker of the VizAblate system that combines ...Learn More
NeoGenomics pays $6M for pathology services firm
NeoGenomics, which specializes in cancer genetic tests, has agreed to pay $6 million to purchase Path Labs, which it will ...Learn More
ViaLogy reverse takeover leads Premaitha to gain AIM listing
Premaitha Health's reverse takeover of ViaLogy has allowed the U.K.-based prenatal test firm to trade stocks on the AIM ...Learn More
EU approves CorTechs Labs' brain imaging tool
Regulators in Europe have given CorTechs Labs CE mark approval for its NeuroQuant software, a volumetric brain imaging tool ...Learn More
Silicon Valley in-depth: Unraveling arrhythmia with iRhythm CEO Kevin King
Kevin King, CEO of Silicon Valley digital health company iRhythm, tells MassDevice about the promise of Big Data and how ...Learn More
DARPA awards $40M for development of brain implant
The University of Pennsylvania, the Lawrence Livermore National Laboratory and the University of California, Los Angeles, ...Learn More
British study shows promise of blood test to predict Alzheimer's
A blood test that identifies a set of 10 proteins can predict the onset of Alzheimer's disease within a year with 87% ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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When it comes to human dignity, we cannot make compromises.
Angela Merkel, German ...Learn More
FDA OKs NeuroMetrix's chronic pain device for nonprescription use
The FDA has cleared NeuroMetrix to market a wearable device designed to treat chronic pain without the need for a ...Learn More
Airway mapping device firm advances $7.5M funding round
A group of 18 undisclosed backers has pumped $6.5 million into Veran Medical Technologies, bringing the company closer to ...Learn More
Mariel buys Stryker's bone morphogenetic protein-7 assets
Mariel Therapeutics has agreed to acquire the bone morphogenetic protein-7 assets of Stryker for undisclosed terms. ...Learn More
Biomatrica licenses reagent technology to Microbiologics
Biomatrica has granted Microbiologics licensing rights for its RNAstable and DNAstable reagents used to stabilize RNA and ...Learn More
Former Acclarent exec named COO of Benvenue Medical
Jeffrey Jones has been tapped to serve as chief operating officer of Benvenue Medical. ...Learn More
Magnetodyn to sell patented bone, tissue regeneration tech
Magnetodyn has struck a deal to sell patents related to its bone and tissue regeneration technology to German firm Munich ...Learn More
Swiss bioinformatics firm obtains $13.75M in Series B financing
A Series B round of financing has pulled in $13.75 million for Sophia Genetics. ...Learn More
Startup behind pill-scanning device gets funding boost
Mint Solutions has raised $6 million in a round of Series A financing headed by Seventure Partners and Life Sciences ...Learn More
Nortis eyes 2015 release of organ-mimicking microfluidic chip
Nortis has obtained $2 million in financing, which CEO Thomas Neumann said will be used to help bring the company's ...Learn More
Uterine fibroid devices to undergo FDA scrutiny
An FDA panel of advisers will convene on Thursday and Friday to explore possible changes to the labeling, instructions for ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Failure is simply the opportunity to begin again, this time more intelligently.
Henry Ford, American ...Learn More
FDA lowers regulatory bar for headache devices
The FDA has lowered the risk classification of noninvasive systems to treat headache from Class III to Class II devices with ...Learn More
N.J. maker of insulin delivery device obtains about $22M
Valeritas has secured approximately $22 million in a funding round that the company hopes will bring in up to $45 million. ...Learn More
Natera enters genetic-test partnership with Mount Sinai
The Mount Sinai Genetic Testing Laboratory has agreed to provide Natera's Horizon test used for genetic-carrier screening. ...Learn More
Former AtriCure CEO takes the helm of JenaValve
David Drachman has been appointed to serve as the new CEO of JenaValve, the maker of a transcatheter aortic valve implant ...Learn More
ArcticDx signs deal to bring its AMD test to Canada
ArcticDx has granted AMD Insight exclusive licensing rights for its Macula Risk PGx assay, designed to assess a patient's ...Learn More
Firms ally to develop tests to customize statin drugs
A deal struck between Genomas and AutoGenomics aims to create genetic assays and DNA-based diagnostic tools that can be used ...Learn More
Advanced X-ray angiography system unveiled by Toshiba
An advanced X-ray angiography device, called Infinix Essential, has been introduced by Toshiba America Medical Systems. ...Learn More
Diazyme's iron deficiency test lands FDA clearance
The FDA has cleared Diazyme Laboratories, a General Atomics unit, to market its ferritin immunoturbidimetric assay for ...Learn More
CAS Medical reaches settlement deal with Covidien unit
CAS Medical said it has agreed to pay Covidien unit Nellcor $275,000 to settle a patent litigation with prejudice. ...Learn More
FDA input sought by Mainstay Medical for ReActiv8 system
A pre-investigational device exemption information package has been presented to the FDA by Mainstay Medical for the ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Let no one ever come to you without leaving better and happier.
Mother Teresa, Albanian-Indian nun and ...Learn More
Thoratec to acquire Apica Cardiovascular for up to $75M
Thoratec has agreed to acquire Apica Cardiovascular for $35 million in cash, plus as much as $40 million in milestone fees. ...Learn More
Shares offering could pull in $6.8M for GeneNews
Toronto-based GeneNews, which specializes in molecular diagnostic tests, seeks to obtain $6.8 million in a private shares ...Learn More
Veracyte's genomic test scores reimbursement win from 2 insurers
Veracyte's Afirma Gene Expression Classifier has been found by Horizon Blue Cross Blue Shield of New Jersey and Highmark to ...Learn More
Echo Therapeutics names interim CEO, looks for new CFO
Kimberly Burke has been tapped to serve as interim CEO of Echo Therapeutics until Aug. 30 or when a permanent CEO is hired. ...Learn More
NuVasive to build global operations center in Ireland
California-based NuVasive, which specializes in minimally invasive spinal surgery devices, is setting up an international ...Learn More
Strong growth forecast for Chinese X-ray imaging market
GlobalData predicts the Chinese market for X-ray imaging systems could be worth $1 billion by 2020, driven in part by the ...Learn More
Medtronic's device fares better than daily injections in diabetes trial
A clinical study of more than 330 participants in Canada found that type 2 diabetes patients using Medtronic's MiniMed ...Learn More
Vital-signs-monitoring chair from EarlySense gains FDA OK
The FDA has cleared EarlySense to market a sensor that can monitor a patient's heart rate, respiratory rate, movement and ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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The important thing is not to stop questioning.
Albert Einstein, German-American theoretical ...Learn More
T2 Biosystems plans to go public to raise $69M
T2 Biosystems, which develops MRI-based infection diagnostic tools, hopes to raise up to $69 million in an initial public ...Learn More
Abiomed pays more than $30M for 2 German medtech firms
Abiomed has agreed to acquire Entwicklungsgessellschaft, a German firm developing a catheter-based heart pump, for $13 ...Learn More
Rotation Medical obtains $27.2M in Series B financing
A Series B funding round has brought in $27.2 million for Rotation Medical, the maker of a collagen scaffold designed to ...Learn More
Report: Worldwide companion Dx market poised for robust growth
A Research and Markets report forecasts that the worldwide companion diagnostics market, which reached $26 billion last ...Learn More
Podcast: Covidien's Enxing Seng talks Medtronic merger, future of medicine at DeviceTalks
Covidien's Stacy Enxing Seng speaks to MassDevice.com about the Medtronic merger during our DeviceTalks Minnesota ...Learn More
Research project aims to evaluate immune competence
The Singapore Immunology Network will work with French molecular diagnostics company ImmunID on a clinical study evaluating ...Learn More
Thermedx's fluid-warming technology wins expanded FDA OK
The FDA has given Thermedx expanded clearance to market its fluid-warming system for use during hysteroscopic and ...Learn More
FDA's 4-year plan includes focus on safety and quality
The FDA has issued a draft document outlining a four-year plan that will focus on five key areas, including regulatory ...Learn More
St. Jude resolves manufacturing issues at Calif. plant
The FDA has issued a notice clearing St. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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SmartBrief will not publish Friday
In observance of Independence Day in the U.S., SmartBrief will not publish on Friday. Publication will resume ...Learn More
Beware; for I am fearless, and therefore powerful.
Mary Shelley, English ...Learn More
Encision gets FDA OK for laparoscopic surgery device
The FDA has granted Encision 510(k) clearance for its AEM EndoShield system, which increases the safety of monopolar ...Learn More
Carlyle wraps up purchase of J&J unit
Private equity group Carlyle has finalized its acquisition of Ortho-Clinical Diagnostics, a unit of Johnson & Johnson. ...Learn More
Funding round brings in $26M for Amedica
Amedica has obtained $26 million in its latest funding round that includes a $20 million loan from Hercules Technology ...Learn More
EU regulators approve Staar Surgical's eye implant
Staar Surgical has received CE mark approval to market its Visian ICL preloaded device in Europe. ...Learn More
Report forecasts strong growth for worldwide digital X-ray market
A MarketsandMarkets report predicts that by 2018, the global market for digital X-ray systems could be worth $8.7 billion, ...Learn More
CompanionDx enters genomics testing partnership with RegenWell
RegenWell has agreed to offer CompanionDx Reference Lab's assays for use by its provider network at the point of care. ...Learn More
OCT spinal fixation device introduced by Zimmer
Zimmer said its Virage OCT Spinal Fixation System is available commercially. ...Learn More
FDA clears augmented reality device for vascular surgery
The FDA cleared Surgical Theater's Surgical Navigation Advanced Platform, which helps guide vascular and brain surgery using ...Learn More
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Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Start where you are. Use what you have. Do what you can.
Arthur Ashe, American professional tennis ...Learn More
Stryker to purchase Small Bone Innovations' assets for about $375M
Stryker has struck a deal to acquire the assets of Small Bone Innovations, including its Scandinavian Total Ankle ...Learn More
Spectranetics' $230M purchase of AngioScore finalized
Spectranetics has wrapped up its purchase of AngioScore, along with its AngioSculpt Scoring Balloon, for $230 million. ...Learn More
Signal Genetics gains OK to offer myeloma test in N.Y.
The New York State Department of Health has granted Signal Genetics approval to offer its Myeloma Prognostic Risk Signature ...Learn More
Illumina signs 3 EU deals for noninvasive prenatal testing
Illumina has struck separate deals with Genoma in Italy, the Center for Human Genetics and Laboratory Diagnostics in Germany ...Learn More
Mainstay gets Belgian OK to expand neurostimulation-device trial
Belgian regulators have given Mainstay Medical the go-ahead to include more sites in a clinical study of its ReActiv8 device ...Learn More
Masimo's patient monitoring tool gains FDA clearance
A patient monitoring and connectivity platform developed by Masimo has obtained 510(k) clearance from the FDA. ...Learn More
Edwards' noninvasive patient monitoring device OK'd by FDA
The FDA has cleared Edwards Lifesciences to market its ClearSight system, which is used for the noninvasive monitoring of ...Learn More
FDA inspectors find no issues at EDAP's manufacturing plant
EDAP said FDA inspectors found no problems at its facility used for the production of its Ablatherm-HIFU technology, a ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Inspiration usually comes during work, rather than before it.
Madeleine L'Engle, American ...Learn More
Health sector leads other industries in deal activity this year
The health care industry is the busiest sector in terms of deal activity this year, with $317.4 billion in transaction value ...Learn More
Investors could pump as much as $62.5M into InSightec
InSightec Image Guided Treatment, a unit of Elbit Medical Technologies, is looking to raise as much as $62.5 million from ...Learn More
Endosurgical device firm could raise $11.1M in funding round
Medigus hopes to obtain $11.1 million in a round of financing from U.S. and Israeli investors. ...Learn More
Corgenix to receive $2.9 million from NIH for Ebola test
Corgenix Medical Corp. has been awarded a grant worth $2.9 million for work on a test for the Ebola virus. ...Learn More
Report: Global breast imaging market poised for growth
A MarketsandMarkets report predicts the international breast imaging market will reach $3 billion in five years, with ...Learn More
Trial begins for Thoratec's advanced heart pump
Thoratec has initiated a clinical study evaluating its HeartMate III system, the latest version of its left ventricular ...Learn More
Roche partners with New Zealand university on molecular Dx lab
A research and development facility is being established by Roche Diagnostics in partnership with New Zealand's Auckland ...Learn More
Draft guidance on nanotech-based products released by FDA
Draft guidance issued by the FDA outlines how the agency intends to regulate products that include nanotechnology, which is ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Every noble work is at first impossible.
Thomas Carlyle, Scottish writer and ...Learn More
Report: Companion Dx market in Western EU could hit $1.295B by 2018
A Frost & Sullivan study predicts the western European market for companion diagnostic tests will see a 23.2% compound ...Learn More
Funding round pulls in $14M for Dune Medical
Dune Medical Devices has obtained $14 million in a funding round and hopes to raise $7 million more. ...Learn More
Shares offering could bring in $5.2M for BSD Medical
BSD Medical hopes to secure $5.2 million through an offering of company shares. ...Learn More
Investors pump $6M into heart monitoring device startup
Whoop, a company that was spun out of the Harvard Innovation Lab, has received about $6 million from 14 backers. ...Learn More
NeoChord appoints new leaders
Former Edwards Lifesciences executive David Chung has been tapped to serve as president and CEO of NeoChord, which develops ...Learn More
Australia, New Zealand OK Titan's interbody fusion system
Regulators in Australia and New Zealand have granted approval for Titan Spine's Endoskeleton system used during interbody ...Learn More
Company behind wearable pain-relief device obtains funds
A regulatory filing disclosed that ZetrOZ, maker of the FDA-cleared sam technology, has secured a little over $2 million in ...Learn More
FDA clears Fujifilm's enhanced digital mammo device
The FDA has cleared Fujifilm Medical Systems USA to market its Aspire Cristalle technology, a digital mammography device ...Learn More
Additional guidelines on device ID system issued by FDA
The FDA has issued a second set of final guidelines governing compliance with the Global Unique Device Identification ...Learn More
Siemens pursues FDA OK for mammo device with tomosynthesis option
An FDA premarket approval application has been filed by Siemens Healthcare for its Mammomat Inspiration technology that ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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Face the facts of being what you are, for that is what changes what you are.
Soren Kierkegaard, Danish philosopher and ...Learn More
Intuitive gains EU approval for advanced surgical robot
Intuitive Surgical has obtained CE mark approval to market the newest version of its da Vinci Xi surgical robot in Europe. ...Learn More
Ornim Medical to set up U.S. shop in Mass.
Ornim Medical, an Israeli maker of blood flow monitoring devices, plans to set up a U.S. base in Foxboro, Mass. ...Learn More
Martha tapped to lead Medtronic's integration with Covidien
Geoff Martha has been appointed to serve as senior vice president and chief integration officer of Medtronic. ...Learn More
China clears Bruker to market microbial ID tool
Chinese regulators have given Bruker the go-ahead to market its IVD MALDI Biotyper in that country. ...Learn More
Courtagen signs Taiwanese supply deal with Bioinn
Courtagen Life Sciences has entered into a distribution deal with Bioinn Molecular Diagnosis for undisclosed terms. ...Learn More
Study backs potential of tomosynthesis in breast cancer screening
Using tomosynthesis in combination with digital mammography improved the detection of invasive breast tumors by 41%, reduced ...Learn More
Device to aid in heart ablation procedures in the works
Aeon Scientific is working on a magnetic device that will allow surgeons to steer the catheter inside the heart precisely ...Learn More
FDA OKs cardiovascular ultrasound scanner from GE
The FDA has cleared GE Healthcare to market its Vivid T8 system, a mobile ultrasound scanner designed to support ...Learn More
Nanosphere wins FDA nod for bacterial portion of molecular Dx test
Nanosphere has been cleared by the FDA to market the bacterial component of its Enteric Pathogens Nucleic Acid Test. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Only the mediocre are always at their best.
Jean Giraudoux, French diplomat and ...Learn More
Abbott's device to treat cataract patients clears EU hurdle
European regulators have given Abbott's Medical Optics unit the green light to market its Tecnis Symfony line of intraocular ...Learn More
IPO could bring in up to $80M for Intersect ENT
California-based Intersect ENT plans to launch an initial public offering in hopes of obtaining as much as $80 million. ...Learn More
Lantheus unveils IPO plans
Lantheus Holdings, the parent company of Lantheus Medical Imaging, has filed for an initial public offering, although it did ...Learn More
Roche signs companion Dx development deal with Ferring
Roche Holding has agreed to use its Elecsys AMH test to create a companion diagnostic for Ferring Pharmaceuticals' ...Learn More
Japan approves diabetes test from NeuroMetrix
NeuroMetrix said Tuesday that it has received the go-ahead to market its NC-stat DPNCheck system in Japan. ...Learn More
GenDx gets CE mark for HLA gene amplification tool
GenDx has earned the CE mark in Europe for its NGSgo-AmpX system, designed to support downstream sequencing by amplifying ...Learn More
Metabolon to conduct prediabetes study with Geisinger
Geisinger Medical Center in Pennsylvania will work with Metabolon on a research project to test whether Metabolon's Quantose ...Learn More
Covidien launches brain aneurysm device in Europe
Covidien is making its Pipeline Flex embolization system available in Europe, which comes on the heels of CE mark approval ...Learn More
FDA moves to address gender gap in device trial data
The FDA says not enough women are enrolled in clinical trials, causing a gap in the information the agency uses to approve ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Feel the power that comes from focusing on what excites you.
Oprah Winfrey, American media mogul and ...Learn More
Cancer Genetics to pay about $6.25M for Gentris
Cancer Genetics has agreed to pay as much as $6.25 million to acquire Gentris, which offers biorepository, genotyping and ...Learn More
Pentagon awards $66.7M in supply contracts to 5 medtech firms
The Department of Defense has awarded supply contracts worth a total of $66.7 million to Welch Allyn, Hologic, iCAD, InVivo ...Learn More
Definiens gets $20.4M boost to expand into digital tissue Dx
A funding round headed by Wellington Partners has brought in $20.4 million for Definiens. ...Learn More
CareFusion's consolidation effort will affect jobs in N.J.
CareFusion will shut down its disposable-device production plant in Totowa, N.J., and will consolidate the facility into its ...Learn More
Former Boston Scientific exec joins Sunshine Heart as operations SVP
Brian Brown has been appointed to serve as senior vice president for operations and technology at Sunshine Heart. ...Learn More
EU allows InspireMD to resume sales of MGuard Prime EPS stent
InspireMD has received the green light to resume distribution of its MGuard Prime EPS stent in Europe. ...Learn More
Titan brings spinal fusion device to U.K., Spain
Titan Spine said its Endoskeleton suite of interbody systems, designed for spinal fusion surgery, is available in Spain and ...Learn More
Calif. glioblastoma patient receives MR-guided laser treatment
A glioblastoma patient at UC San Diego Health System has received MR-guided laser therapy using Monteris Medical's ...Learn More
Philips installs NeuroSuite technology at Swedish hospital
The NeuroSuite X-ray technology developed by Philips has been installed for the first time at Karolinska University Hospital ...Learn More
Draft guidance eases oversight of medical device data systems
Data systems used with medical devices, medical image communication systems and image storage tools would not be subject 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
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Recognizing the need is the primary condition for design.
Charles Eames, American ...Learn More
Allied Minds reduces London IPO target to $130M
The amount that Allied Minds looks to obtain in its initial public offering in London has been reduced from $140 million to ...Learn More
Mass. maker of mitral valve repair device gets $8.1M boost
Massachusetts-based Mitralign, which has developed a catheter-delivered device used to treat patients with functional mitral ...Learn More
Funding round brings in $6.3M for Courtagen
A regulatory filing disclosed that Courtagen Life Sciences has secured approximately $6.3 million from unnamed investors. ...Learn More
Medacta's relocation could add about 50 jobs in Chicago
Medacta USA has transferred its U.S. base from Southern California to a 20,000-square-foot space in Chicago. ...Learn More
Israeli medtech incubator acquires patent for prostate cancer tech
Israeli medical-device incubator Trendlines Group has acquired patents covering technology it co-developed with Endo Health ...Learn More
Malaysia implements 5 new medical device policies
Malaysian regulators have adopted new rules governing medical devices as a result of the Medical Device Act that recently ...Learn More
Itamar Medical strikes deal to bring heart Dx tool to Japan
Itamar Medical, the Israeli maker of the EndoPAT diagnostic system designed to monitor the heart and blood vessels, has ...Learn More
Wrist fusion plating device released by Acumed
Acumed said its device designed to treat patients with post-traumatic arthritis of the wrist joints is available ...Learn More
Qardio gains FDA OK for blood pressure monitoring tool
The FDA has given Qardio 510(k) clearance to market QardioArm, a pocket-size device used to monitor a patient's blood ...Learn More
23andMe submits FDA application for bloom syndrome test
The FDA has accepted 23andMe's 510(k) clearance application for use of its genetic test kit in evaluating a single genetic ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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I wasn't anything special as a father. But I loved them and they knew it.
Sammy Davis Jr., American ...Learn More
IRadimed hopes to raise $12M from IPO
IRadimed, which develops MRI-safe devices, plans to launch an initial public offering in hopes of obtaining as much as $12 ...Learn More
Colo. vascular device maker obtains about $5.8M
A regulatory filing disclosed that EndoShape has obtained more than $5.8 million in a funding round aiming for almost $6.8 ...Learn More
Quest's new facility in Kan. could create 500 jobs
Quest Diagnostics is opening a 78,000-square-foot national service center in Lenexa, Kan. ...Learn More
InVivo names permanent CFO
Steven McAllister, who has been serving as interim chief financial officer of InVivo Therapeutics since December, has been ...Learn More
Expert outlines ways to streamline medtech review in China
Promptly providing supplementary information is key to shortening the product-approval process in China, said Ed Woo, ...Learn More
Cepheid enters rapid Dx development partnership with 3 drugmakers
A collaboration between Cepheid, GlaxoSmithKline, AstraZeneca and Cubist Pharmaceuticals has been launched to create a rapid ...Learn More
Blood test detects heart transplant rejection faster than biopsy, study finds
A new blood test can detect heart transplant rejection up to five months earlier than a biopsy, Stanford University ...Learn More
Laparoscopic surgical instruments released by CareFusion
CareFusion has released its MicroLap surgical product line, which includes hand instruments, scopes, access tools and ...Learn More
Posterior spinal device from ulrich is available
The uCentum Comprehensive Posterior System, designed for minimally invasive and open spinal surgical procedures, has been ...Learn More
FDA urged to ID ways to minimize device application withdrawals
A new Booz Allen Hamilton report offers 11 recommendations to improve the FDA's medical device review process, including the ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Love is a canvas furnished by nature and embroidered by imagination.
Voltaire, French writer and ...Learn More
IPO pulls in $46.7M for Pixium Vision
An initial public offering has brought in $46.7 million for France-based Pixium Vision. ...Learn More
Volcano wraps up purchase of AtheroMed for close to $117M
Volcano's acquisition of AtheroMed, along with its Phoenix atherectomy catheter technology, for about $116.5 million in cash ...Learn More
Spinal-device startup obtains $64M in Series E, debt financing
Benvenue Medical, maker of the Kiva VCF system designed to offer an alternative to balloon kyphoplasty in treating vertebral ...Learn More
MicroPort's facility expansion in Tenn. could create 171 jobs
China-based MicroPort Orthopedics, which specializes in knee and hip implants, reportedly looks to spend $100 million in the ...Learn More
Quest looks to add 350 jobs at Fla. facility by 2015
Quest Diagnostics plans to invest $9.3 million in its new 48,000-square-foot national logistics hub in Tampa, Fla. ...Learn More
Invivoscribe strikes molecular Dx deal with Alliance Global
Invivoscribe Technologies has entered into a distribution deal with Dubai, UAE-based Alliance Global Group. ...Learn More
Former Medtronic CEO cheers $43B Covidien deal
The merger of medical device giants Medtronic and Covidien has a range of implications both for those companies and for ...Learn More
New A-fib trial results show efficacy of Medtronic's defibrillator
New results from an ongoing study found that heart failure patients who received Medtronic's AdaptivCRT defibrillators saw a ...Learn More
Partnership aims to develop tests to ID circulating tumor cells
Fluxion Biosciences will work with the Stanford University School of Medicine to develop molecular diagnostic assays that ...Learn More
Firm developing tissue scaffold wins medtech innovation challenge
Fibralign, which is working on an extracellular matrix scaffold with 3D-oriented fibrils that mimic human tissues, has been ...Learn More
Qiagen's cytomegalovirus test cleared by FDA
The FDA has cleared Qiagen to market its artus CMV RGQ MDx kit, which runs on the company's Rotor-Gene Q MDx real-time ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Not admitting a mistake is a bigger mistake.
Robert Half, American ...Learn More
Medtech prices barely budged over 23 years, AdvaMed study finds
A new AdvaMed study found that medical device spending rose from 5.3% to 5.9% of U.S. ...Learn More
For more:
Read the AdvaMed press release about the group's latest medtech price ...Learn More
U.S. orthopedic trauma market could hit $8B in 6 years, report says
An iData Research report predicts that by 2020, the U.S. ...Learn More
IPO could bring in as much as $12.1M for Signal Genetics
The amount that Signal Genetics seeks to obtain in its planned initial public offering has been increased from about $9.3 ...Learn More
Comments sought on revised medtech registration proposal in Brazil
ANVISA, Brazil's medtech regulatory agency, is seeking public input on proposed changes to certain medical device ...Learn More
Mayo Clinic partners with Enterome on personalized nutrition test
Enterome Bioscience has agreed to work with the Mayo Clinic to identify and validate gut microbiome-based tests that can be ...Learn More
2 medtech companies win awards at Mich. business-plan challenge
Genomenon placed first in the New Business Idea category of this year's Great Lakes Entrepreneurs Quest business plan ...Learn More
Knee and hip arthroplasty device from OrthAlign wins FDA OK
The FDA has given OrthAlign 510(k) clearance for its OrthAlign Plus Technology, which is expected to reach the market in the ...Learn More
Next-gen device to treat vertebral fractures released by VEXIM
VEXIM introduced at a recent conference in Paris a next-generation version of its SpineJack system, designed to repair ...Learn More
FDA proposes social media guidelines for pharma, medtech
Two draft guideline documents were issued Tuesday by the FDA requiring pharmaceutical and medtech companies to balance ...Learn More
EnteroMedics gets mixed FDA panel review for obesity device
An FDA panel has agreed that EnteroMedics' Maestro VBLOC neurostimulation system is safe and that its benefits are greater ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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Work on the accent; it will enliven the whole.
Pierre Bonnard, French ...Learn More
Edwards' next-gen heart valve gains FDA approval
The FDA has granted Edwards Lifesciences approval for its Sapien XT system, a next-generation transcatheter aortic valve ...Learn More
Calif. intraocular lens maker closes $30M funding round
PowerVision, maker of the FluidVision intraocular lens used to treat presbyopia and cataracts, has completed its Series D ...Learn More
Illumina enters supply partnership with CareDx
CareDx, which specializes in transplant molecular diagnostics, has entered into a supply deal with Illumina for undisclosed ...Learn More
Bladder cancer test firm obtains more than $5M in financing
A funding round has pulled in more than $5 million for Nucleix, whose lead product is the Bladder EpiCheck test used to ...Learn More
Hill-Rom to buy German OR equipment-maker for $250M
Hill-Rom has entered into a deal to acquire Trumpf Medical, a German maker of surgical tables and other operating-room ...Learn More
GenomeDx's prostate cancer test to be covered by Prime Health
Prime Health Services has agreed to provide coverage for GenomeDx's Decipher prostate cancer assay. ...Learn More
Advanced heart stimulator released by Biotronik
Biotronik has announced the launch of its Qubic Stim technology, an advanced version of its universal heart stimulator. ...Learn More
Sequenom wins FDA nod for Impact Dx platform, thrombophilia assay
Sequenom has received FDA clearance for its Impact Dx platform as well as its Impact Dx Factor V Leiden and Factor II ...Learn More
FDA clears influenza test from Alere
The FDA has given Alere clearance to market an assay that can identify and distinguish A and B strains of the flu virus. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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The world doesn't care how many times you fall down, as long as it's one fewer than the number of times you get back up.
Aaron Sorkin, American ...Learn More
Covidien to be acquired by Medtronic for $42.9B
Medtronic has announced it will pay $42.9 billion in cash and stock to acquire Covidien and its medical-device lines in a ...Learn More
Stentys finalizes buyout of Cappella stent delivery system for $1.4M
Stentys has wrapped up its purchase of Cappella's Peel Away stent delivery system for $1.4 million in cash and company ...Learn More
Medtronic partners with Sanofi on diabetes initiative
Medtronic has entered into a strategic partnership with French pharmaceutical firm Sanofi, with the goal of enhancing ...Learn More
Abbott seeks patent extension for drug-eluting stent
Abbott has filed with the U.S. ...Learn More
Biocartis strikes companion Dx deal with Abbott
Biocartis has entered into a development and marketing deal with Abbott for undisclosed terms. ...Learn More
EU commission seeks more data on Zimmer, Biomet merger deal
The European Commission said Zimmer's submission regarding its pending merger with Biomet is incomplete and has discarded ...Learn More
ViaLogy to pay $17.8M for U.K. molecular Dx firm
U.K.-based Premaitha Health has agreed to a reverse takeover by ViaLogy, an investment group, for $17.8 million. ...Learn More
Firm wins medtech challenge award for IVD test platform
Atomo Diagnostics won a gold medal for its AtomoRapid system in the in vitro diagnostic category of the recent Medical ...Learn More
FDA issues initial guidelines on device ID data submission
The first set of final guidelines governing the submission of unique device identification data to the FDA by medtech ...Learn More
IHealth's blood glucose monitor receives FDA clearance
IHealth Lab has announced the release of its iHealth Align system, which comes on the heels of FDA clearance for the device. ...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
Life is too challenging for external rewards to sustain us. The joy is in the journey.
Bradley Whitford, American ...Learn More
Medtronic wins expanded FDA OK for artificial heart valve
The FDA has granted Medtronic expanded approval for its CoreValve transcatheter aortic valve replacement system, allowing ...Learn More
Bard's $500M stock buyback plan wins board approval
A plan by C.R. ...Learn More
Hospital GPO awards orthopedic implant contract to Integra unit
Premier, a hospital group purchasing organization, has awarded a supply contract to Integra LifeSciences' orthopedics and ...Learn More
BGI taps Genomed to bring prenatal test to Poland
Genomed has entered into a distribution deal with BGI Europe for undisclosed terms. ...Learn More
Trial enrollment begins for Cardiovascular Systems' artery device
Cardiovascular Systems has initiated patient enrollment in a clinical study of its microcrown Orbital Atherectomy System, a ...Learn More
Zyga begins trial enrollment for sacroiliac joint fusion device
Zyga Technology has enrolled the first patient in a clinical trial of its SImmetry Sacroiliac Joint Fusion System, designed ...Learn More
3 devices released by RightBio to measure gastric pH levels
RightBio Metrics has announced the launch of its RightLevel pH Detector, RightSpot pH Indicator and RightSpot Infant pH ...Learn More
Mass. firm wins award for OCT imaging device
NinePoint Medical's NvisionVLE imaging system, a volumetric optical coherence tomography tool, received a silver medal at ...Learn More
Action plan to overhaul FDA's medtech review process issued
The FDA's device center has laid out a two-stage action plan for improving its medical-device review process. ...Learn More
For more:
Read the AdvaMed press release commending the Booz Allen Hamilton report on the device review ...Learn More
Bard receives FDA panel support for PAD device
A panel of FDA advisers has unanimously agreed to endorse approval for C.R. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Other people's faults are like bees -- if we don't see them, they don't harm us.
Luis Vigil, Spanish writer and ...Learn More
Covidien's neurovascular microcatheter gains FDA approval
The FDA has given Covidien the green light to market its Apollo Onyx system, a delivery microcatheter that has a detachable ...Learn More
Hollister to spend $108M on Irish manufacturing facility
Hollister plans to make an investment worth about $108 million for its manufacturing plant in Ballina, Ireland. ...Learn More
CURA Healthcare lands $6M investment
Peepul Capital has pumped $6 million into CURA Healthcare, a firm based in India that specializes in diagnostic imaging ...Learn More
Calif. firm developing wearable GI monitor obtains $350K
Breakout Labs has provided $350,000 in financing to G-Tech Medical, which is working on a wearable sensor patch that could ...Learn More
Updated EU standards on heart implants to take effect July 31
Makers of extracorporeal devices and cardiovascular implants in Europe have until July 31 to comply with new EU standards ...Learn More
FDA cybersecurity rejections are on the way
The FDA is ramping up its cybersecurity labs and may start rejecting insecure technologies sooner than you think. ...Learn More
DFINE begins trial enrollment for tumor ablation device
DFINE has enrolled the first patients in a clinical study evaluating its STAR tumor ablation device, which uses ...Learn More
Utah university begins trial of BSD's tumor ablation device
The University of Utah School of Medicine has initiated a clinical trial to test the use of the MicroThermX technology in ...Learn More
Symmetry's total hip arthroplasty device debuts at conference
Symmetry Medical unveiled its Dual Connection Offset Acetabular Reamer Driver at an orthopedic conference this week in ...Learn More
Medtronic completes FDA application for PAD device
Medtronic has forwarded to the FDA the final module of its premarket approval application for the In.Pact Admiral system. ...Learn More
FDA clears latest mammo version of M-Vu CAD tool
Mammography version 3.1 of VuCOMP's M-Vu CAD system has obtained clearance from the FDA. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
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There is always the need to carry on.
Marjory Stoneman Douglas, American journalist and ...Learn More
FDA panel sets review date for Cohera's surgical adhesive
An FDA panel will meet Aug. ...Learn More
Computer-aided surgical tools and robotics market could hit $4.6B in 2019
A BCC Research report forecasts that the worldwide market for computer-aided surgical tools and medical robotics could be ...Learn More
Quest to offer BioMerieux's companion Dx test for 2 melanoma drugs
Quest Diagnostics has added to its companion diagnostic portfolio BioMerieux's THxID-BRAF test, a polymerase chain reaction ...Learn More
Roche's HPV test gets Canadian OK for cervical cancer screening
Roche has received the green light in Canada to market its cobas 4800 HPV test for use as a first-line cervical-cancer ...Learn More
Japan approves Kinamed's trauma and orthopedic surgery device
Japanese regulators have given Kinamed the go-ahead to market its SuperCable Polymer Cerclage System, designed for various ...Learn More
S. Korea plans to regulate IVD reagents as medical devices
In vitro diagnostic reagents marketed in South Korea would be regulated as medical devices, rather than as drug products, ...Learn More
ElectroCore's neurostimulation device shows promising trial results
ElectroCore Medical said its gammaCore system, a handheld device used to treat migraine and severe headaches by stimulating ...Learn More
RaySearch hits milestone for pencil-beam scanning technique
RaySearch Laboratories has announced that its pencil-beam scanning technology has been used for the first time in a patient ...Learn More
Bioventus announces U.S. debut of advanced bone-healing device
An advanced version of the Bioventus EXOGEN Ultrasound Bone Healing System is now available commercially in the U.S. ...Learn More
FDA OKs Auxogyn's device used in embryo viability assessment
Auxogyn has been cleared by the FDA to market its Eeva System, a time-lapse photography tool designed to help doctors ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
I don't believe in luck -- I believe in preparation.
Bobby Knight, American basketball ...Learn More
Medtronic to acquire wireless-monitoring-device firm
Medtronic said it has agreed to pay an undisclosed sum to acquire Corventis in a deal that could be finalized this month. ...Learn More
Company developing TMS device advances $11.9M funding round
Cervel Neurotech, which is working on a device that delivers repetitive transcranial magnetic stimulation to treat mental ...Learn More
AITbiotech signs molecular Dx distribution deal with Becton unit
AITbiotech, which develops molecular diagnostic tests designed for research use, has entered into a distribution deal with ...Learn More
Firms partner to bring cancer screening to Caribbean, Central America
Cancer Genetics and AstraZeneca CAMCAR have struck a deal to offer cancer screening in the Caribbean and Central America ...Learn More
German Dx device firm launches R&D facility in Calif.
Germany-based diagnostic-device maker BIT Group has announced the launch of its research-and-development hub in Irvine, ...Learn More
Medtech career seminar for veterans set for next week in Boston
The first Student Veteran Re-careering Seminar in the Boston area will be held June 17 by Abiomed, in partnership with North ...Learn More
Women's cancer registry gains support from Intuitive Surgical
Intuitive Surgical, which develops surgical robotic devices, has joined other industry groups in sponsoring the Society of ...Learn More
Micra transcatheter pacing system debuts in U.K.
A patient at Southampton General Hospital has become the first in the U.K. ...Learn More
Latent tuberculosis can be identified by blood test, study finds
A new test that uses interferon-gamma release assays appears to be capable of detecting latent tuberculosis. ...Learn More
Medicare coverage for lung-cancer screening urged by Congress
Senate and House lawmakers, along with several industry groups, have asked the CMS and the HHS to grant full Medicare ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Opportunity can be manufactured. Yes, you can wait around for the right set of circumstances to fall into place and then leap into action, but you can also create those sets of circumstances on your own.
Biz Stone, American ...Learn More
Pentagon awards $1.9M for nerve-repair tech development
AxoGen will work with Brigham and Women's Hospital in Boston to develop devices that could aid in peripheral-nerve-repair ...Learn More
Mass. hemodynamic monitoring device firm lands $5M investment
HighCape Partners has invested $5 million in Cheetah Medical, a Massachusetts-based maker of a noninvasive hemodynamic ...Learn More
Philips works with Teva to operate drug, medtech incubator
Philips Medical Systems has joined forces with Teva Pharmaceutical Industries to launch a Chief Scientist technology ...Learn More
Asia-Pacific bone-growth substitute, spinal-implant market poised for growth
The market for bone-graft substitutes and spinal implants in the Asia-Pacific region could be worth $7 billion by 2022, ...Learn More
EU approves Sphere Medical's blood analyzer
European regulators have given Sphere Medical the CE mark to market its Proxima system, designed for use in blood analysis. ...Learn More
Arthrosurface reports first use of ToeMotion system in U.S.
A doctor at the University of Pittsburgh Medical Center has carried out the first total toe procedures in the U.S. ...Learn More
Electronic pill designed for GI imaging unveiled by Check-Cap
Check-Cap has introduced an electronic pill that allows 3D imaging of the gastrointestinal tract using a radiation dose akin ...Learn More
2 ACL reconstruction devices introduced by DePuy unit
DePuy Synthes Mitek Sports Medicine showcased two devices to be used during anterior cruciate ligament reconstructions at a ...Learn More
AcuFocus gets mixed FDA panel review for presbyopia device
An FDA panel has agreed that AcuFocus' Kamra inlay system is effective in improving near and intermediate vision in patients ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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If the path be beautiful, let us not ask where it leads.
Anatole France, French ...Learn More
Cantel Medical to acquire endoscopy firm for $26.9M
Cantel Medical has agreed to pay $26.9 million to acquire PuriCore International, a U.K. ...Learn More
IPO could bring in as much as $50M for CareDx
CareDx has announced plans to launch an initial public offering in hopes of obtaining as much as $50 million. ...Learn More
Welch Allyn buys certain assets of vision tech developer
Welch Allyn, which specializes in point-of-care diagnostics, has purchased some of the assets of PediaVision. ...Learn More
Strong growth forecast for N. American interventional device market
A MarketsandMarkets report predicts that by 2018, the market for interventional cardiology and peripheral vascular systems ...Learn More
Funding round brings in $1.9M for wireless ECG device firm
A Series A funding round led by The Martin Cos. has pulled in $1.9 million for InvisionHeart. ...Learn More
China approves Waters' Acquity UPLC TQD system
Chinese regulators have given Waters the go-ahead to market its Acquity UPLC TQD technology in that country. ...Learn More
Boston Scientific enrolls first patients in heart valve study
Boston Scientific has begun patient enrollment in a postmarket registry trial evaluating its Lotus technology, a ...Learn More
Trauma screw system from Tyber Medical wins FDA nod
The FDA has given 510(k) clearance to a headless cannulated trauma screw system developed by Tyber Medical. ...Learn More
Medtech execs meet with congressman to discuss industry roadblocks
The U.S. ...Learn More
For more:
Read the AdvaMed press release about the round-table meeting with Rep. Brad ...Learn More
FDA OKs advanced balloon catheter from TriReme Medical
The FDA has cleared TriReme Medical, a unit of QT Vascular, to market its Chocolate PTCA 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
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
Art is the signature of civilizations.
Beverly Sills, American opera ...Learn More
Stentys agrees to buy stent delivery device-maker
Cappella Peel Away, along with its stent delivery technology, will be acquired by Stentys for an undisclosed sum. ...Learn More
B. Braun joins forces with CeGaT to create diagnostics firm
CeGaT and B. Braun Medical have joined forces to set up a company in the U.S. ...Learn More
Calif. startup developing presbyopia device obtains funds
LensGen, a California-based startup that is developing an intraocular lens to treat presbyopia, has secured half of its $4 ...Learn More
Maker of artificial cervical disk raises $34M
Spinal Kinetics has obtained $34 million in a funding round, which the company will use in part to launch a clinical study ...Learn More
Irish medtech, IVD regulator to adopt new name
The Irish Medicines Board, which regulates medical devices, in vitro diagnostic tools and other medical products in Ireland, ...Learn More
S. Korean devices would get expedited access to Mexican market
COFEPRIS, Mexico's medtech regulator, has agreed to allow expedited market access for medical devices that have marketing ...Learn More
Aptitude's online marketplace has $10B in hospital buying power. What does that mean for medtech?
Executives from Aptitude, the online medical device marketplace that aims to be the Amazon.com of medtech, check in with ...Learn More
MedImmune taps Ventana to create companion Dx for lung cancer drug
Ventana has entered into a development deal with MedImmune for undisclosed terms. ...Learn More
Wis. business-plan challenge awards top prize to Elucent
Elucent Medical, which has developed a wireless marker and detection device that surgeons can use to better locate breast ...Learn More
DexCom's professional continuous glucose monitor gets FDA OK
The FDA has granted DexCom premarket approval for a professional version of its continuous glucose monitor. ...Learn More
HeartWare warned over manufacturing issues at Fla. plant
The FDA has issued a warning letter to HeartWare over manufacturing practice violations at its facility in Florida. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Hope is the only bee that makes honey without flowers.
Robert Ingersoll, American orator and political ...Learn More
Medtronic's advanced diabetes device gains EU approval
European regulators have granted Medtronic the CE mark to market its MiniMed Duo system, which is used in conjunction with ...Learn More
Maker of blood-glucose-monitoring device gets $20M boost
Maryland-based Senseonics has obtained $20 million in a round of financing from existing backers. ...Learn More
Sysmex signs colorectal-cancer-test development deal with Merck
Sysmex Inostics has agreed to work with Merck KGaA to create a biomarker assay that could be used to detect metastatic ...Learn More
Former Guidant and Abbott exec takes the helm of Biosensors
Jose Calle Gordo, who formerly worked at Guidant and Abbott Vascular, has been tapped to serve as CEO of Biosensors ...Learn More
EU approves Covidien's respiration-rate system
Covidien has announced the immediate release of its Nellcor Respiration Rate system, which comes on the heels of CE mark ...Learn More
AdvaMed will strengthen efforts in China with new office
AdvaMed has received the green light to set up an office in Shanghai. ...Learn More
For more:
Read the press release about AdvaMed's new office in ...Learn More
NanoString, Celgene sign companion Dx deal for lymphoma candidate
NanoString Technologies agreed to develop a companion diagnostic test that will be used to screen patients for a pivotal ...Learn More
Orthopedic guidewire from SafeWire gets FDA OK
The FDA has given SafeWire 510(k) clearance for its Y-Wire 2 orthopedic guidewire, designed for use during spinal ...Learn More
FDA OKs automated breast ultrasound system from GE
The FDA has granted GE Healthcare approval for its Invenia system, designed as an ancillary tool to mammography in ...Learn More
T2 seeks FDA clearance for pathogen Dx test and instrument
T2 Biosystems has submitted to the FDA an application seeking 510(k) clearance for its T2Candida test and T2Dx system. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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To love for the sake of being loved is human, but to love for the sake of loving is angelic.
Alphonse de Lamartine, French writer and ...Learn More
St. Jude wraps up $455M purchase of CardioMEMS
St. Jude Medical has finalized its purchase of CardioMEMS for $455 million. ...Learn More
Imperial Innovations eyes $250M from shares offering
Imperial Innovations, a U.K.-based technology commercialization firm, is hoping to secure $250 million in a public shares ...Learn More
Montagu, Astorg unveil plans to acquire Sebia
Montagu Private Equity and Astorg Partners said they are in exclusive discussions to buy Sebia from Cinven for undisclosed ...Learn More
Report: Global orthopedic sales could surpass $54B in 4 years
An ORTHOWORLD report forecasts that global sales of orthopedic products will grow from more than $44.6 billion last year to ...Learn More
British firm gets $8.4M boost for point-of-care Dx tool
QuantuMDx, a British firm specializing in molecular diagnostics, has obtained $8.4 million in its latest funding round. ...Learn More
Firm wins $1.49M grant to develop brain surgical sealant
The National Institute of Neurological Disorders and Stroke has awarded a $1.49 million grant to Endomedix under the ...Learn More
Genovel enters partnership for knee osteoarthritis device
Genovel Orthopedics, a unit of HC2 Holdings, has entered into a research and licensing deal with New York University. ...Learn More
Smartphone-based inhaler from Nexus6 wins FDA nod
The FDA has cleared Nexus6 to market its SmartTouch system as a prescribable metered dose inhaler for use in clinical ...Learn More
AdvaMed CEO calls for prompt action on device tax repeal
The 2.3% medical device tax has cost as many as 165,000 U.S. ...Learn More
For more:
Read the AdvaMed report, Impact of the Medical Device Excise ...Learn More
FDA announces launch of open data program
The FDA has announced the pilot launch of openFDA, a program meant to give the public, Web developers and researchers easier ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...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
We must be willing to get rid of the life we've planned, so as to have the life that is waiting for us.
Joseph Campbell, American writer and ...Learn More
Smith & Nephew, ArthroCare seal $1.7B merger deal
Smith & Nephew has finalized its purchase of ArthroCare, which comes after the deal received "unconditional clearance" from ...Learn More
Biotech incubator spins out vascular access device firm
Novita, a biotech incubator in Kansas, has spun off early-stage vascular device firm Flow Forward. ...Learn More
Pa. maker of respiratory assist device gets $10M boost
Pennsylvania-based ALung Technologies has obtained $10 million in financing, which Chairman and CEO Peter DeComo said would ...Learn More
Agilent signs companion Dx development deal with Merck
Dako, a unit of Agilent Technologies, has struck a development deal with Merck for undisclosed terms. ...Learn More
VistaMed to add 125 new positions at Irish plants
VistaMed, which specializes in extrusion and catheter systems, said it plans to add 125 new positions at its manufacturing ...Learn More
Program awards grants to 2 smartphone-based diagnostic devices
Biophotonics firm MobileOCT, which is working to transform any digital camera into a tool for identifying abnormal cell ...Learn More
Nextremity's metatarsal shortening device wins U.S., EU nod
Nextremity Solutions has secured FDA clearance and CE mark approval in Europe for its device used during metatarsal ...Learn More
Olympus readies advanced therapeutic gastroscope
Olympus is preparing to launch the EVIS EXERA III GIF-1TH190 system, a therapeutic gastroscope with advanced features such ...Learn More
Sensory Medical gains FDA clearance for RLS device
Sensory Medical has been cleared by the FDA to market its Relaxis system, a noninvasive and nondrug means of treating ...Learn More
FDA OKs clinical study of Active's meniscus implant
The FDA has granted Active Implants investigational device exemption approval to launch a clinical study of its NUsurface ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Winning is a habit. Unfortunately, so is losing.
Vince Lombardi, American football player and ...Learn More
Medtronic agrees to $9.9M settlement of lawsuit with DOJ
Medtronic has agreed to pay $9.9 million to the Department of Justice to settle a lawsuit in which it was accused of ...Learn More
Premia Spine advances $10M financing round
A funding round aiming for $10 million has brought in $7 million for Premia Spine. ...Learn More
Cartagenia signs distribution deal with Agilent, gets $5.9M boost
Cartagenia has agreed to allow Agilent to resell its Bench Lab CNV module, which is used to analyze and report copy number ...Learn More
Egyptian regulator OKs BSD Medical's ablation device
BSD Medical has received the go-ahead from the Ministry of Health in Egypt to market its MicroThermX microwave ablation ...Learn More
Sciencewerke to offer Courtagen's NGS-based tests worldwide
Courtagen Life Sciences has entered into a global distribution deal with Sciencewerke, a marketing and distribution firm ...Learn More
Partnership aims to develop upper GI cancer detection tool
Verisante Technology has partnered with Astoria Capital to set up a Polish joint venture focused on developing a device that ...Learn More
Software shows promise in detecting autism symptoms
Autism screening software that tracks eye movements matched the performance of experienced clinicians in spotting behavioral ...Learn More
Device to treat ankle fractures released by OsteoMed
The ExtremiLOCK Ankle Plating System, designed to address fractures of the fibula and distal tibia, has been introduced by ...Learn More
FDA eases regulatory oversight for pancreatic stents
The FDA has agreed to reclassify pancreatic drainage stents from Class III to Class II medical devices with special ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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No bird soars too high if he soars with his own wings.
William Blake, British painter and ...Learn More
CardioMEMS receives FDA approval, takeover bid from St. Jude
The FDA has granted CardioMEMS approval to market an implantable device used to help doctors monitor heart failure patients ...Learn More
Spectranetics agrees to pay $230M for AngioScore
Spectranetics has agreed to pay $230 million to acquire AngioScore, which manufactures specialty balloon catheters designed ...Learn More
Robust growth forecast for companion Dx market
A GlobalData report forecasts that the market for companion diagnostic tools will see 4.9% growth compounded annually, with ...Learn More
Meridian's pneumonia, pertussis tests win approval in Canada
Health Canada has given Meridian Bioscience the go-ahead to market a pair of molecular tests used to identify the presence ...Learn More
China OKs joint CRM venture between Sorin, MicroPort
Chinese regulators have granted MicroPort Scientific and Sorin approval to set up a joint venture focused on cardiac rhythm ...Learn More
Backboard to boardroom: Jonathan Bender's journey from NBA star to medtech entrepreneur
Former NBA player Jonathan Bender tries his hand at entrepreneurship, aiming to bring the physical therapy device he ...Learn More
DARPA teams up with UCSF, Mass General for brain implant research
The Defense Advanced Research Projects Agency is funding a $70 million, five-year program to test implanted electronic ...Learn More
Device to isolate CTCs from blood samples is available
The ClearCell FX System, a cancer diagnostic tool co-developed by Clearbridge BioMedics and Cambridge Consultants, became ...Learn More
W.Va. hospital goes digital using Agfa's DR system
Mon General Hospital, a 189-bed acute-care facility in West Virginia, has finished converting its analog X-ray room to ...Learn More
FDA issues new details on compliance with device ID rule
The FDA has posted on its website new details regarding compliance with the unique device identifier system for medical ...Learn More
Dispute-resolution panel for FzioMed's Oxiplex gel postponed
A dispute-resolution panel scheduled for June 10 to consider the FDA's 2008 decision to deny approval for FzioMed's Oxiplex ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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You may not control all the events that happen to you, but you can decide not to be reduced by them.
Maya Angelou, American ...Learn More
Volcano to pay $115M for peripheral artery device firm
Volcano has agreed to pay $115 million in cash to acquire AtheroMed in a deal that could be finalized by the end of the ...Learn More
U.K. molecular Dx firm Lab21 agrees to merge with Novacyt
Lab21, a U.K. firm specializing in molecular diagnostics, has signed a merger deal with Novacyt of France. ...Learn More
BioTime unit enters lung cancer Dx partnership with Cornell
OncoCyte, a BioTime unit, has agreed to work with Cornell University to develop an assay for diagnosing lung cancer. ...Learn More
PPO agrees to cover Pacific Edge's bladder cancer test
MultiPlan, a preferred provider organization, has agreed to provide reimbursement coverage for Pacific Edge's Cxbladder ...Learn More
Firms collaborate to develop portable in-home hemodialysis device
Debiotech, AWAK and Neokidney, an initiative of the Dutch Kidney Foundation, have signed a joint venture agreement to create ...Learn More
Accuray's CyberKnife M6 system makes Australian debut
A patient suffering from brain metastasis has been treated successfully using Accuray's CyberKnife M6 robotic radiosurgery ...Learn More
CardioKinetix's heart implant shows promising trial results
Early results of a clinical study showed that CardioKinetix's Parachute implant led to improved cardiac function in heart ...Learn More
3 orthopedic devices released by DePuy Synthes
DePuy Synthes said the CORAIL Revision Hip System, which comes with a bone-preserving capability, and the GLOBAL UNITE ...Learn More
Device tax hinders industry growth, Ind. companies tell senator
The medical device tax, as well as the slow process of getting FDA approvals, is hindering the industry's expansion efforts, ...Learn More
Qiagen's companion Dx for colorectal cancer drug wins FDA nod
Qiagen has obtained the FDA's approval to market its therascreen KRAS RGQ PCR assay as a companion diagnostic test for ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Whatever your discipline, become a student of excellence in all things. Take every opportunity to observe people who manifest the qualities of mastery. These models of excellence will inspire you and guide you toward the fulfillment of your highest...
Tony Buzan and Michael Gelb, ...Learn More
ENeura gets FDA OK for device to treat migraine
The FDA has cleared eNeura to market a mobile stimulator that uses transcranial magnetic stimulation to treat pain in ...Learn More
CareDx signs agreement to acquire ImmuMetrix
CareDx has announced that it has entered into a deal to purchase transplant diagnostic company ImmuMetrix. ...Learn More
Targos enters cancer biomarker partnership with WuXi
Targos has agreed to work with WuXi PharmaTech to validate and assess cancer tissue biomarkers using Targos' biomarker ...Learn More
PerkinElmer signs global distribution deal with Sebia
Sebia has struck a distribution deal with PerkinElmer for undisclosed terms. ...Learn More
Ohio device firm garners industry honors for drug safety system
Ohio-based Codonics has been selected as a Medical Design Excellence Award finalist for its Safe Label System, which ...Learn More
Perfint's cancer care device gains FDA nod
The FDA has granted India-based Perfint Healthcare clearance for its Maxio robotic tool designed to boost cancer care by ...Learn More
Pencil-beam feature for RayStation 4.0 system scores FDA OK
RaySearch has been cleared by the FDA to equip its RayStation 4.0 proton therapy planning technology with a pencil-beam ...Learn More
EKOS wins FDA clearance for device to treat pulmonary embolism
EKOS has secured FDA clearance to market its EcoSonic Endovascular System for use in treating pulmonary embolism in a less ...Learn More
Immucor's molecular test for blood compatibility gets FDA approval
The FDA has granted Immucor approval for its Precise Type Human Erythrocyte Antigen Molecular BeadChip Test. ...Learn More
Fisher's infant CPAP nasal prong recall labeled Class I by FDA
A recall issued by Fisher & Paykel Healthcare involving some of its infant nasal CPAP prongs has been categorized by the FDA ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Joy is the simplest form of gratitude.
Karl Barth, Swiss ...Learn More
Smith & Nephew's merger with ArthroCare approved by U.K. regulators
The acquisition of ArthroCare by Smith & Nephew for $1.7 billion has received "unconditional clearance" from antitrust ...Learn More
J&J to pursue regulatory approvals for 30 devices through 2016
The medical device and diagnostics unit of Johnson & Johnson plans to submit 30 major products for regulatory approval in ...Learn More
Funding round brings in $17M for heart monitoring device firm
A funding round headed by Danish biotech investment firm Novo has pulled in $17 million for iRhythm Technologies. ...Learn More
MGC Diagnostics announces management changes
Gregg Lehman is stepping down as CEO of MGC Diagnostics and will be replaced by Todd Austin, the company's executive vice ...Learn More
EU's proposed UDI system promises greater transparency through central database
The European Union's implementation of universal device identification systems in medical devices is awaiting progress on ...Learn More
Biotronik wins EU nod for ProMRI system
European regulators have given Biotronik the go-ahead to market its ProMRI system, designed to enable patients with cardiac ...Learn More
Program to improve clinical trials gets $37.5M boost from FDA
The FDA said it will allocate as much as $37.5 million to aid the Clinical Trials Transformation Initiative in its mission ...Learn More
NeuroMetrix announces Japanese release of diabetes Dx device
NeuroMetrix said its NC-stat DPNCheck system is available commercially in Japan through Omron Healthcare, the company's ...Learn More
Review date for EDAP's prostate cancer device set by FDA panel
An FDA panel will convene on July 30 to consider EDAP TMS' premarket approval application for its Ablatherm-HIFU system, ...Learn More
FDA seeks to reclassify certain antigen-based influenza assays
The FDA has issued a proposal to recategorize certain antigen-based assays used to identify the presence of influenza in ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
AdvaMed SmartBrief will not publish Monday
In observance of Memorial Day in the U.S., AdvaMed SmartBrief will not be published Monday. Publication will resume ...Learn More
All wish to possess knowledge, but few, comparatively speaking, are willing to pay the price.
Juvenal, Roman ...Learn More
Abiomed wins FDA nod to expand right-side heart pump study
Abiomed has received the go-ahead from the FDA to enroll as many as 22 additional patients in a clinical study of its ...Learn More
Ohio molecular Dx firm obtains financing worth $32M
Assurex Health has obtained a $25 million loan and investments worth $7 million. ...Learn More
Mich. tissue ablation device firm advances $14.22M financing round
HistoSonics has secured roughly $14.17 million of a hoped-for $14.22 million financing round. ...Learn More
Whole Biome signs microbiome Dx deal with Mayo Clinic
Whole Biome has entered into a development deal with Mayo Clinic Center for Individualized Medicine for undisclosed terms. ...Learn More
Nyxoah secures about $11M for sleep apnea device
A funding round has pulled in almost $11 million for Nyxoah, a firm based in Belgium and Israel that is working on a device ...Learn More
Silicon Valley in-depth: Tapping medtech's Big Data with AliveCor CEO Euan Thomson
AliveCor's interim-ish CEO Euan Thomson talks about the data-driven future, why he jumped ship at Accuray and how to ...Learn More
U.S. pivotal trial of Direct Flow's TAVI device gets FDA OK
The FDA has granted Direct Flow Medical an investigational device exemption to conduct a pivotal study of its transcatheter ...Learn More
Chest monitor from Vital Connect lands FDA clearance
The FDA has cleared Vital Connect to market its HealthPatch MD system, a chest monitor that features a sensor and a ...Learn More
Monteris launches 3-Tesla brain surgery stabilization tool
A 3-Tesla, MRI-safe model of the AtamA system has been released in Canada and the U.S., according to Monteris Medical, which ...Learn More
W.Va. hospital installs VuCOMP's mammo software
Mon General Hospital in West Virginia has completed the installation of the M-Vu CAD for mammography system from VuCOMP. ...Learn More
FDA plans workshop on use of 3D printing in medtech
The FDA plans to host a workshop to gain public input on whether it should develop rules governing the use of additive ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
All progress is experimental.
John Jay Chapman, American ...Learn More
Medtech sector saw surge in M&A activity in Q1, report says
A PricewaterhouseCoopers report found that the value and volume of merger and acquisition deals in the medical device sector ...Learn More
$9.7M grant allocated for medtech innovation center in Mass.
A grant worth $9.7 million has been approved by the Massachusetts Life Sciences Center and Gov. ...Learn More
AtriCure plans to move headquarters to Mason, Ohio
The Ohio Tax Credit Authority has awarded tax incentives to AtriCure to help create new jobs as the company relocates its ...Learn More
Microarray instrument sales boost Q1 revenues for Arrayit
California-based Arrayit posted $1.1 million in total revenues during the first quarter, an increase from $942,916 during ...Learn More
London IPO could bring in $140M for Allied Minds
Allied Minds, a U.S.-based technology transfer firm, plans to launch an initial public offering in London in hopes of ...Learn More
EU approves Medtronic's coronary balloon dilation catheter
European regulators have granted Medtronic approval to market its NC Euphora system, a coronary balloon dilation catheter ...Learn More
Ark. Dx firm gets $2M boost to advance breast cancer assay
Arkansas-based Ascendant Dx has obtained $2 million in financing, which the company will use to develop and commercialize ...Learn More
Gauss' surgical blood loss monitoring tool gets FDA OK
Gauss Surgical has received FDA approval for its Triton Fluid Management System to be used in the operating room. ...Learn More
FDA sets review date for Bard's PAD device
An FDA panel will convene on June 12 to consider whether to recommend premarket approval for C.R. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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The roots of education are bitter, but the fruit is sweet.
Aristotle, Greek ...Learn More
Medtech firms opted for M&A deals to fill portfolio niches in Q1
A Walden Group report found that during the first quarter, many medical device manufacturers embarked on acquisitions to ...Learn More
Colo. surgical device firm obtains $7.5M from 50 investors
A round of 50 backers has pulled in $7.5 million for JustRight Surgical, maker of a 5-millimeter surgical stapling device ...Learn More
Joint disease Dx startup sets up shop in Del.
CD Diagnostics, a Pennsylvania-based startup that develops tests used to diagnose joint disease, has opened an office in ...Learn More
Funding round brings in $14M for Israeli implant device firm
Keystone Heart, maker of the TriGuard implant used to help protect the brains of patients undergoing transcatheter valve ...Learn More
Medical devices cut costs and contribute to economy, exec says
The cost of medical devices has remained consistently low for the past two decades, writes Biomet President and CEO Jeffrey ...Learn More
Philips launches tool used during embolization procedures
The EmboGuide system, designed to help interventional radiologists view tumors and feeder blood vessels during embolization ...Learn More
Urine test indicates presence of blood clots in the lungs
A urine test that measures levels of fibrinopeptide B can be used to detect pulmonary embolisms, according to research ...Learn More
Ohio hospital to use EOS Imaging's technology
Cincinnati Children's Hospital Medical Center has installed EOS Imaging's technology for integration into its regular ...Learn More
Deep brain stimulation device keeps N.H. patient's tremors under control
Kelly Smith, who was diagnosed with a nervous system disorder known as essential tremor, has regained control of her life ...Learn More
High court decision ends patent dispute between Baxter, Fresenius
An appeal filed by Baxter over a patent dispute with Fresenius has been rejected by the U.S. Supreme Court. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
A good leader takes a little more than his share of the blame, a little less than his share of the credit.
Arnold Glasow, American businessman and ...Learn More
CareFusion looks to offer $1B in senior notes
CareFusion looks to sell senior notes worth a total of $1 billion, which are due in 2017, 2024 and 2044. ...Learn More
N.Y. cancer Dx firm reduces IPO target
The amount that Signal Genetics hopes to obtain in its planned initial public offering has been reduced from $25 million to ...Learn More
2 imaging firms enter distribution partnership
Analogic has agreed to market its BK Flex Focus tool in combination with D&K Technologies' BioJet technology in the U.S. ...Learn More
Staar Surgical announces management changes
David Choromanski has been tapped by Staar Surgical to serve as senior director of consumer marketing for the company's ...Learn More
Compliance dates for implant traceability plan announced in Argentina
Argentinian regulators have announced two compliance deadlines for the country's national device traceability plan that took ...Learn More
IVD module added to Malaysia's online medtech application system
The Medical Device Authority in Malaysia has updated MeDC@St, its online system for registering medical devices sold in that ...Learn More
CMS proposal would provide coverage for Abott's MitraClip system
Abbott's MitraClip system, an FDA-approved transcatheter mitral valve repair device, would receive Medicare reimbursement ...Learn More
IMDx gains FDA clearance for HPV test
IMDx has secured FDA clearance for its IMDx HSV-1/2 test to be used on the Abbott m2000 platform. ...Learn More
FDA lowers risk classification for Given Imaging's pill camera
The FDA has agreed to recategorize the PillCam system developed by Given Imaging, a Covidien unit, as a Class II medical ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...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
What we think, or what we know, or what we believe is, in the end, of little consequence. The only consequence is what we do.
John Ruskin, British art critic, writer and ...Learn More
Boston Scientific pays $415M for Bayer's interventional device unit
Boston Scientific has agreed to pay $415 million to acquire Bayer Interventional, a Bayer unit focused on devices used to ...Learn More
Health care VC deals in Q1 dominated by medtech, biotech firms
A CB Insights report found that venture capital transactions for biotech and medical device firms made up 27% of all deals ...Learn More
Minn. sleep apnea device firm obtains $40M in fresh capital
Minnesota-based Inspire Medical Systems has received $40 million in its latest funding round, led by OrbiMed. ...Learn More
Orgentec hires 2 former Beckman Coulter executives
Orgentec Diagnostika, a German firm focused on infectious disease and autoimmune diagnostic tests, has appointed Scott ...Learn More
EU approves Elixir Medical's next-gen coronary stent
Regulators in Europe have given Elixir Medical the go-ahead to market a next-generation version of its DESolve system, a ...Learn More
Report forecasts growth for global fluoroscopy, mobile C-arms market
A BCC Research report predicts that by 2018, the worldwide market for mobile C-arms and fluoroscopy systems could be worth ...Learn More
VA awards imaging contracts to Agilex, Calgary Scientific
Agilex and Calgary Scientific have been tapped by the Department of Veterans Affairs to enhance the department's remote and ...Learn More
Startup behind malaria Dx device wins top prize in MIT challenge
The Disease Diagnostic Group has received around $145,000 for winning the top prize in the MIT$100K entrepreneurship ...Learn More
FDA panel proposes reclassification of intravascular, colon devices
An FDA panel has recommended that the agency downgrade colon capsule imaging tools and intravascular administration sets ...Learn More
FDA clears combined HSV-VZV test from Quidel
The FDA has granted Quidel clearance for its Lyra Direct HSV 1+2/VZV test under the agency's de novo program. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Those who believe in telekinetics, raise my hand.
Kurt Vonnegut, American ...Learn More
Pixium Vision plans to go public in France
Pixium Vision has filed for an initial public offering in France, but it did not disclose its IPO target. ...Learn More
Steris' $165M purchase of Integrated Medical Systems finalized
Steris has completed its purchase of Integrated Medical Systems for roughly $165 million. ...Learn More
Texas spinal implant-maker eyes $32.1M from stock sale
Texas-based LDR, which specializes in implantable spine systems and instrumentation, is looking to obtain $32.1 million ...Learn More
Medrobotics gets $26M boost for robot-assisted surgical device
Medrobotics has obtained $26 million in Series E financing, which the company aims to use to begin commercial sales of its ...Learn More
Former GE executive tapped to lead Medtronic's diabetes unit
Hooman Hakami has been appointed to serve as executive vice president and group president of Medtronic's diabetes unit, ...Learn More
Response strikes deal to bring molecular tests to Mexico
Response Genetics has entered into a distribution deal with DxM Diagnostico Molecular under undisclosed terms. ...Learn More
St. Jude begins U.S. trial enrollment for aortic valve
Patients in New York City and Los Angeles became the first to be implanted with St. ...Learn More
2 CT scanners from Siemens Healthcare gain FDA clearance
The FDA has cleared Siemens Healthcare to market two versions of its Somatom Perspective CT scanner. ...Learn More
FDA issues 35th update to list of recognized standards
The FDA's device center has made another revision to the list of third-party standards recognized by the agency for use by ...Learn More
BioView wins FDA nod for device to detect ALK rearrangements
BioView has secured clearance from the FDA to market its Duet System. ...Learn More
Advice is what we ask for when we already know the answer but wish we didn't.
Erica Jong, American ...Learn More
Medtronic wins Canadian approval for implantable heart monitor
Medtronic has announced the commercial release of its Reveal LINQ system in Canada, which comes on the heels of a marketing ...Learn More
Calif. surgical device firm obtains $18M
A round of debt and venture capital financing has pulled in $18 million for Ceterix Orthopaedics. ...Learn More
MDxHealth signs marketing deal for prostate cancer test
MDxHealth has entered into a marketing deal with American Pathology Partners for undisclosed terms. ...Learn More
Former executive at J&J unit joins Hologic as CFO
Robert McMahon has been tapped to serve as the new chief financial officer at women's health device firm Hologic. ...Learn More
French ultrasound device firm strikes supply deal with U.S. GPO
Resource Optimization and Innovation, a U.S. ...Learn More
6-month data show positive results for Boston Scientific's spine stimulator
Boston Scientific reported positive results from a clinical trial evaluating its Precision Spectra stimulator, designed to ...Learn More
GE launches SpinLab, teams with CorTechs Labs
GE Healthcare has launched the SpinLab hyperpolarizing technology, which is used to image cellular metabolism based on MRI ...Learn More
Olympus prepares to launch 2 bronchoscopes
A pair of devices used for small anatomy and peripheral bronchoscopy are being launched by Olympus. ...Learn More
FDA explores regulatory approach for proteomic tests
The FDA plans to devise a framework for regulating research-level proteomic tests intended to be used as in vitro diagnostic ...Learn More
GOP senators press for vote on rolling back device tax
Republican senators are pushing to have the repeal of the medical device tax included in the $85 billion tax extension ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
No effort that we make to attain something beautiful is ever lost.
Helen Keller, American author and ...Learn More
AcuFocus lands FDA review date for device to treat presbyopia
An FDA panel will meet on June 6 to discuss AcuFocus' premarket approval application for its Kamra Inlay system, a ...Learn More
Cardinal Health wraps up $320M purchase of AccessClosure
Cardinal Health's $320 million purchase of AccessClosure, which specializes in extravascular closure systems, has been ...Learn More
Aimago's acquisition by Novadaq finalized
The purchase of Aimago by Novadaq Technologies, announced last month, has been completed. ...Learn More
Elekta announces management changes
Asa Hedin has been promoted from head of Elekta's neuroscience division to executive vice president of corporate strategy. ...Learn More
Foundation Medicine wins EU approval for cancer assay
Foundation Medicine has received the go-ahead to market its FoundationOne assay in Europe. ...Learn More
Ga. firm gets $6M boost for late-stage microneedle studies
A funding round has pulled in $6 million for Clearside Biomedical, which has licensed a microinjection tool used to help ...Learn More
Partnership aims to discover lupus biomarkers
Berg will work with the University of South Carolina to identify biomarkers that could signal lupus onset and progression. ...Learn More
Ultrasound fusion imaging tool from Esaote gets FDA OK
The FDA has cleared Esaote to market its Virtual Navigator software, designed to fuse CT, PET, MR or 3D ultrasound with ...Learn More
FDA seeks comments on voluntary consensus standards proposal
The FDA has issued draft guidelines on how voluntary consensus standards should be used when submitting premarket ...Learn More
Stance on use of 3D printing in medtech could come from FDA soon
A statement detailing the FDA's stance on the use of 3D printing to develop medical devices could be issued soon, FDA ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
You really have to love yourself to get anything done in this world.
Lucille Ball, American comedian and ...Learn More
DermTech eyes $25M from IPO; Siemens plans audiology unit spinoff
DermTech, which is working on an RNA-based melanoma diagnostic test, is seeking $25 million in an initial public offering. ...Learn More
Eurofins Scientific pays $255M for ViraCor
Eurofins Scientific has agreed to pay $255 million to purchase ViraCor-IBT Laboratories, a Missouri-based company that ...Learn More
CompanionDx signs pharmacogenomics testing deal with Enable
CompanionDx Reference Lab has agreed to supply pharmacogenomics testing services to Enable Healthcare's physician network ...Learn More
Boston Scientific exec joins CareFusion's board
Supratim Bose has been tapped to serve on CareFusion's board of directors. ...Learn More
Abbott wins award for Irish vascular-device plant
The Huntsman Business School at Utah State University has granted the Shingo Prize to Abbott's vascular-device facility in ...Learn More
1-year trial results show St. Jude's pacemaker going strong
St. ...Learn More
Scientists create liverlike device that provides blood detox
Scientists at the University of California, San Diego, have created a three-dimensional printed device that can be used ...Learn More
Device for bone-tissue regeneration designed for skull-damage repair
Researchers at Rice University have developed a medical gel that uses patients' stem cells to promote bone regeneration. ...Learn More
DEKA's robotic device for amputees obtains FDA approval
DEKA Integrated Solutions received FDA approval for its DEKA Arm System, an advanced prosthetic device that can aid amputees ...Learn More
Advanced Circulatory wins FDA panel vote for CPR device
A panel of FDA advisers agreed to recommend approval for Advanced Circulatory Systems' ResQCPR technology. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Courage is being scared to death and saddling up anyway.
John Wayne, American ...Learn More
K2M proceeds with IPO valued at $120M
Leesburg, Va.-based K2M, which specializes in surgical devices used to treat spinal disorders and injuries, has moved ahead ...Learn More
Calif. maker of acid reflux device closes $30M funding round
A Series G funding round has pulled in $30 million for EndoGastric Solutions, maker of a surgical tissue-stapling device ...Learn More
Funding round brings in $28M for Calif. genetic testing firm
California-based Counsyl has obtained $28 million in a Series D round of financing, which it will use to support product ...Learn More
Ark. insulin-pump-maker obtains $2M in Series B financing
SFC Fluidics has raised $2 million in a Series B funding round, which the Fayetteville, Ark.-based company aims to use to ...Learn More
Golden Gate to purchase medical device manufacturing services firm
Golden Gate Capital has agreed to purchase Phillips-Medisize, which provides manufacturing services to medical device ...Learn More
Becton Dickinson to invest about $22M in Irish facility
Becton, Dickinson and Co. ...Learn More
HRS 2014 cheat sheet: This week at the Heart Rhythm Society's 35th Annual Scientific Sessions
The schedule at this year's conference of the Heart Rhythm Society includes notable entries on lead-free implantable ...Learn More
Abbott signs companion Dx development deal with Idera
Abbott has struck a development deal with Idera Pharmaceuticals for undisclosed terms. ...Learn More
ISO certification granted to extremity orthopedic device firm
The British Standards Institution has granted EDGE Orthopaedics ISO certification for the company's quality management ...Learn More
Firm launches peak flow meter, updates asthma software
AsthmaMD has introduced the AsthmaMD Peak Flow Meter, which is intended for use with the AsthmaMD application. ...Learn More
GOP senators take issue with FDA's use of draft guidances
Sens. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Love all, trust a few, do wrong to none.
William Shakespeare, British playwright and ...Learn More
Biotronik gains FDA approval for MRI-safe pacemaker
The FDA has granted Biotronik approval to market its Entovis pacemaker that features the company's ProMRI system. ...Learn More
Uncertainty over medical device tax remains, survey finds
A Kadence International survey commissioned by MassMEDIC revealed that fewer than 10% of the 119 Massachusetts-based medtech ...Learn More
Calif. cancer Dx company secures $10M loan
Oxford Finance has granted Biocept a credit facility worth $10 million. ...Learn More
Surgical device firm's Puerto Rico expansion could add 30 jobs
Aspen Surgical Puerto Rico, which specializes in disposable surgical products, has announced plans to increase its ...Learn More
Elekta strikes $20M supply deal in Canada
The Centre Hospitalier de l'Universite de Montreal has awarded a supply contract worth more than $20 million to Elekta. ...Learn More
Study links St. Jude's quadripolar leads to higher survival rates
St. ...Learn More
Nextremity's bunion-correction device hits U.S. market
The Re+Line Bunion Correction System by Nextremity Solutions is now available commercially in the U.S., the company ...Learn More
Report shows increased FDA medtech surveillance
FDA inspections of foreign medtech companies increased 93% in 2012, compared with a 37% increase in overall inspections that ...Learn More
Becton Dickinson obtains FDA clearance for bacterial GI device
The FDA has cleared Becton Dickinson to market its BD Max Enteric Bacterial Panel. ...Learn More
New online, multimedia resource for type 2 diabetes education
Type 2 diabetes is a global epidemic, affecting more than 350 million people worldwide. ...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 world hates change, yet it is the only thing that has brought progress.
Charles Kettering, American ...Learn More
Boston Scientific pays $65M for intrauterine-tissue removal device firm
Boston Scientific has agreed to pay $65 million to purchase IoGyn, which has developed the Symphion device used in ...Learn More
Intuitive Surgical announces $1B share repurchase program
Intuitive Surgical, which develops robotic surgery devices, said it will repurchase $1 billion of its common shares from ...Learn More
Maker of fracture device obtains $10M loan
Conventus Orthopaedics has secured a credit facility worth $10 million, which it will use to help bring its Conventus DRS ...Learn More
Mass. wound Dx device startup hopes to raise $1M
Sano is looking to raise $1 million in seed funding, which the Massachusetts-based startup would use to bring its Woundchek ...Learn More
Breast cancer test fuels Q1 revenue growth for Genomic Health
Genomic Health posted $67 million in revenues during the first quarter, an increase from $63.1 million during the same ...Learn More
Mazor Robotics' device used with imaging feature debuts in Russia
A doctor in Russia has successfully carried out the first spinal procedures using Mazor Robotics' Renaissance Guidance ...Learn More
Stereotaxis wraps up clinical study of catheter device
Stereotaxis said it has concluded a clinical study of the Vdrive with V-Loop Variable Loop Catheter Manipulator and has ...Learn More
Upgraded asthma and COPD device lands FDA clearance
An enhanced version of the Propeller system, which is used to help monitor and manage chronic obstructive pulmonary disease ...Learn More
FDA approves study of Biosensors' drug-eluting stent
Biosensors International has received an investigational device exemption from the FDA to begin a clinical study of its ...Learn More
Siemens Healthcare wins FDA nod for angiography device
The FDA has cleared Siemens Healthcare to market its Artis One technology, which features the company's ClearStent Live ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The louder he talked of his honor, the faster we counted our spoons.
Ralph Waldo Emerson, American ...Learn More
Covidien confirms buyout of Zephyr Technology
Covidien executive Rhonda Luniak has confirmed reports that the company paid an undisclosed sum to acquire Zephyr ...Learn More
N.C. robotic surgery device firm gets $52.2M boost
TransEnterix has obtained $52.2 million in its just-completed public shares offering. ...Learn More
Former American Medical Systems exec named CFO of Orthofix
Mark Heggestad, former chief financial officer and executive vice president of American Medical Systems, has been tapped to ...Learn More
Strong growth forecast for global medtech market
A report from Market Research Reports predicts that the worldwide market for medical devices will see 6.2% annual growth ...Learn More
Boston Scientific takes part in medical innovation effort
Boston Scientific has become the latest to join Optum Labs, an initiative led by the Mayo Clinic and UnitedHealth Group to ...Learn More
Infectious diarrhea Dx panel from bioMerieux gets FDA OK
The FDA has cleared bioMerieux to market its FilmArray Gastrointestinal Panel, a 22-target panel that can detect viruses, ...Learn More
AccelSPINE's next-gen spinal device lands FDA clearance
AccelSPINE has been cleared by the FDA to market its Picasso II technology, a next-generation device designed to promote ...Learn More
Report shows surge in FDA's device user fee collection
A quarterly report found that medical device companies paid the FDA $96.8 million in user fees during fiscal year 2013, a ...Learn More
FDA OKs C. difficile test, molecular Dx platform from Qiagen
The FDA has given Qiagen 510(k) clearance to market its artus C. ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
AdvaMed launches "Med Tech Minute" video series on the value of medical technology
In the first installment in a new video series on the value of life-changing medical technology, Michael T. ...Learn More
We can often endure an extra pound of pain far more easily than we can suffer the withdrawal of an ounce of accustomed pleasure.
Sydney Harris, American ...Learn More
Boston Scientific gets Japanese OK for Promus Premier stent
Japanese regulators have given Boston Scientific the go-ahead to market its Promus Premier system, a coronary drug-eluting ...Learn More
Rights offering brings in $45M for Accelerate Diagnostics
Accelerate Diagnostics has closed its rights offering that began last month, bringing in a total of $45 million. ...Learn More
Foreign investors pump about $31.7M into GI Dynamics
A private placement involving foreign backers has pulled in roughly $31.7 million for GI Dynamics, maker of the EndoBarrier ...Learn More
Innoblative Designs nabs top prize in business-plan challenge
Innoblative Designs has received $78,000 for winning the top prize in the Global Venture Labs Investment Competition at the ...Learn More
Chinese medtech market presents opportunities, challenges
The medical-device market in China has experienced double-digit growth for at least the past 10 years, a trend that is ...Learn More
Veracyte taps Fleury to bring thyroid cancer test to Brazil
Veracyte and Fleury Medicine and Health have entered into a marketing deal for undisclosed terms. ...Learn More
Report predicts strong growth for orthopedic-device market
A Research and Markets report forecasts that the worldwide market for orthopedic systems will grow from $29.2 billion two ...Learn More
Firm wraps up trial enrollment for bioresorbable scaffold
Soft Tissue Regeneration has wrapped up patient enrollment in a clinical study of the L-C Ligament bioresorbable scaffold, ...Learn More
Smart-sensing mouthguard designed to ID concussion
Force Impact Technologies has designed a mouthguard that uses motion sensors and an illuminated strip to help detect hits to ...Learn More
U.S. patent covering cervical fusion device issued to TransCorp
TransCorp Spine has secured a U.S. patent for its locking plate intended for use during anterior cervical fusion surgery. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...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
Preconceived notions are the locks on the door to wisdom.
Merry Browne, ...Learn More
Medtronic's diagnostic, adaptive pacemaker clears EU hurdle
Medtronic said its Viva CRT-P system is available commercially in Europe, which comes on the heels of a CE mark approval for ...Learn More
2 VC groups plan to invest up to $172M in biotech startups
Morgenthaler Ventures and Advanced Technology Ventures have announced plans to put up a venture capital fund for early-stage ...Learn More
Maker of microbiome-based tech platform obtains $13.9M
The first tranche of Enterome's Series B funding round has pulled in $13.9 million, which it would use to support business ...Learn More
Cardiac rhythm management devices help boost Q2 profit for Greatbatch
Greatbatch generated $14.9 million in profits during the second quarter, up from $5.7 million during the same period last ...Learn More
Report: Worldwide electrosurgery market could hit $4B in 5 years
A MarketsandMarkets report predicts that the worldwide market for electrosurgery devices will be worth $4 billion in 2019. ...Learn More
EU approves heart-mapping catheter from Acutus Medical
Acutus Medical has earned the CE mark to market its Katheter system in Europe. ...Learn More
U.S. research center first to install Siemens' advanced MRI scanner
The University of Minnesota's Center for Magnetic Resonance Research has installed Siemens Healthcare's Magnetom Prisma MRI ...Learn More
Inspire Medical gets FDA OK for sleep apnea device
The FDA has granted Inspire Medical Systems approval for its Upper Airway Stimulation technology, an implantable device akin ...Learn More
FDA finalizes guidelines on pediatric device data submission
The FDA has issued final guidance meant to improve the safety of medical devices used in children. ...Learn More
GE gains FDA nod for mobile-based angiography system
The FDA has cleared GE Healthcare to market its mobile-based angiography system called the Discovery IGS 740. ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
New online, multimedia resource for type 2 diabetes education
Type 2 diabetes is a global epidemic, affecting more than 350 million people worldwide. ...Learn More
The ultimate test of a relationship is to disagree but to hold hands.
Alexandra Penney, American artist and ...Learn More
CardioDx resurrects IPO plans; Lombard goes public in U.S.
CardioDx, which specializes in noninvasive cardiovascular disease diagnostic tests, has revived its plans to launch an ...Learn More
Funding rounds pull in $47.25M for Integrated Diagnostics
Integrated Diagnostics has secured a total of $47.25 million through a Series B funding round and debt financing. ...Learn More
Vasculogic seeks $1.5M to advance automated venous access system
Vasculogic is looking to obtain $1.5 million to help finance a clinical study of its VenousPro system, which combines ...Learn More
U.S. nonfusion spinal tools and disk Dx market poised for growth
A Global Information report predicts that the market for nonfusion spinal systems and disk diagnostics tools in the U.S. ...Learn More
U.K. molecular Dx firm closes $28.4M funding round
The final tranche of Atlas Genetics' Series B funding round has been completed, bringing in a total of $28.4 million. ...Learn More
Israeli surgical device firm obtains $1M
Gordian Surgical, an Israeli firm developing a device used to open and seal abdominal incisions during laparoscopic surgery, ...Learn More
Medtronic's heart valve implant shows positive results in 5-year study
Medtronic has reported that its 3f Enable system, a sutureless heart valve replacement device, demonstrated promising ...Learn More
Diagnovus to offer eosinophilic esophagitis Dx test
Diagnovus has secured a license to market the Engauge GI-EoE test, designed by scientists at Cincinnati Children's Hospital ...Learn More
Tougher review considered by FDA for surgical mesh kits
The FDA is considering reclassifying surgical mesh kits, designed to treat pelvic organ prolapse, from Class II to Class III ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
High expectations are the key to everything.
Sam Walton, American ...Learn More
Sorin's next-gen bioprosthetic valve gains FDA approval
The FDA has granted Sorin approval to market a next-generation version of its Mitroflow line of bioprosthetic valves. ...Learn More
Financing round brings in $33M for SI-BONE
SI-BONE, which develops devices used to diagnose and treat low-back problems in patients with sacroiliac joint disorders, ...Learn More
Startup developing PAD diagnostic device seeks $5M in financing
MESI, a Slovenia-based startup that has developed a novel device to take ankle brachial index measurements, is seeking $5 ...Learn More
Robust growth forecast for global medical robot systems market
A report from MarketsandMarkets predicts that the worldwide market for medical robot systems will grow from $1.8 billion ...Learn More
French Dx firm taps Diaxonhit for HIV companion Dx development
French diagnostics firm Bpifrance has awarded a grant worth $2.4 million to Diaxonhit. ...Learn More
V Wave reports first implantation of catheter-delivered shunt
V Wave said its catheter-delivered shunt, designed to treat congestive heart failure, has been implanted for the first time ...Learn More
Voluntis obtains funds to launch diabetes software in U.S.
French mobile-health-application developer Voluntis has raised $29 million in a funding round, which it plans to use to ...Learn More
Firm gears up for U.S. roll-out of bone fixation device
BioMedical Enterprises is launching its Speed Shift Continuous Active Compression System across the U.S. ...Learn More
Study to determine best practices for exploring patient views about medical devices
The FDA has awarded the Medical Device Innovation Consortium close to $500,000 to investigate patient views regarding ...Learn More
FDA OKs glucose management software from Monarch Medical
The FDA has cleared Monarch Medical Technologies to market its EndoTool IV software, designed to help clinicians monitor ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
New online, multimedia resource for type 2 diabetes education
Type 2 diabetes is a global epidemic, affecting more than 350 million people worldwide. ...Learn More
The key to everything is patience. You get the chicken by hatching the egg, not by smashing it.
Arnold Glasow, American businessman and ...Learn More
Novadaq buys skin perfusion imaging device firm Aimago
Aimago, a spinoff of the Swiss academic and research institution Ecole Polytechnique Federale de Lausanne, has been acquired ...Learn More
Ariosa Diagnostics sets price range for planned IPO
Ariosa Diagnostics said it plans to sell 3.5 million company shares in an initial public offering at $16 to $18 apiece. ...Learn More
GI imaging "pill" helps boost Q2 sales for Covidien
Covidien posted a 4% rise in overall sales to $1.21 billion during the second quarter, driven in large part by increased ...Learn More
Intuitive wraps up purchase of Luna's shape-sensing tech
Intuitive Surgical has paid Luna Innovations another $6 million, finalizing its deal to acquire the latter's shape-sensing ...Learn More
Former CareFusion executive named to Orthofix's board
James Hinrichs has been tapped to serve on Orthofix's board of directors. ...Learn More
U.S. medtech startup that moved to Switzerland obtains $26.2M
A funding round headed by European private equity firm Life Sciences Partners has pulled in $26.2 million for Sequana ...Learn More
Infectious disease Dx market in developing economies on the rise
A Frost & Sullivan report finds the market for infectious-disease diagnostics in Latin America, Africa, Asia and other ...Learn More
Ablative gets FDA OK to launch studies of infusion catheter
The FDA has given Ablative Solutions the go-ahead to initiate clinical trials of its Peregrine System Infusion Catheter, ...Learn More
MRI-based device designed for improved jaw, eye imaging
ScanMed of Resonance Innovations has developed an MRI-based device that it says offers physicians a better alternative to ...Learn More
FDA issues draft guidelines on devices subject to PMA process
The FDA will accept comments through July 22 on its draft guidance governing medical devices subject to the premarket ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
AdvaMed launches "Med Tech Minute" video series on the value of medical technology
In the first installment in a new video series on the value of life-changing medical technology, Michael T. ...Learn More
In nature there are neither rewards nor punishments -- there are consequences.
Robert Ingersoll, American orator and political ...Learn More
Roche's HPV test approved as first-line cervical cancer screening tool
The FDA has granted Roche approval for its cobas HPV assay to be used as a first-line cervical cancer screening tool for ...Learn More
Funding round pulls in $10M for Baxano Surgical
Baxano Surgical obtained $10 million in its recently completed financing round. ...Learn More
Illumigene molecular tests help boost fiscal Q2 sales for Meridian
Meridian Bioscience posted $50.1 million in net sales during its fiscal second quarter, up from $47.3 million during the ...Learn More
Konica expands retrofit distribution partnership with GE
Konica Minolta Medical Imaging has agreed to expand its retrofit distribution deal with GE Healthcare. ...Learn More
Israeli firm obtains funds to bring GI devices to Chinese market
Smart Medical Systems, an Israeli maker of colonoscopy and endoscopy devices, has received a $6.5 million investment from ...Learn More
Agendia strikes drug evaluation deal with Daiichi Sankyo
Agendia has entered into a development deal with Japanese drugmaker Daiichi Sankyo. ...Learn More
Spinal devices from Aurora Spine obtain FDA clearance
The FDA has cleared Aurora Spine to market new sizes of its ZIP ULTRA Minimally Invasive Interspinous Fusion System, ...Learn More
Cook Medical to manufacture device to address GI bleeding
The Instinct Endoscopic Hemoclip, designed to halt bleeding in the gastrointestinal tract, is being launched by Cook ...Learn More
Senate hopeful calls device tax "a job killer"
Former Massachusetts Sen. ...Learn More
FDA OKs multiplex digital radiography system from Siemens
Siemens Healthcare has secured FDA clearance to market the Multix Select DR technology. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The greatest trap in our life is not success, popularity or power, but self-rejection.
Henri Nouwen, Dutch ...Learn More
Zimmer to purchase Biomet for $13.4B
Forgoing the option of pursuing an initial public offering, Biomet Inc., parent company Biomet Group Inc., announced ...Learn More
Siemens gains FDA clearance for advanced CT scanner
The FDA has cleared Siemens Healthcare to market its Somatom Force CT scanner, the latest addition to the company's ...Learn More
Stock offering could bring in $200M for Neovasc
Neovasc announced plans to launch a stock offering in hopes of obtaining as much as $200 million. ...Learn More
Maker of patient monitoring device obtains $20M
Sotera Wireless has secured $20 million in fresh capital, bringing its total fundraising to nearly $50 million. ...Learn More
Quest Diagnostics' purchase of Summit Health finalized
Quest Diagnostics has completed its acquisition of Summit Health, a Michigan-based company providing wellness services. ...Learn More
Finding qualified personnel remains challenge for European medical device auditors
A self-auditing exercise by the European Association for Medical Devices of Notified Bodies found that more than half of ...Learn More
Will Medicare patients be left out of the bionics revolution?
We're in the middle of a revolution in prosthetics, with true bionic integration just over the horizon. ...Learn More
U.S. study of Medtronic's MRI-safe defibrillator begins
A patient at Marquette General Hospital in Michigan became the first to receive Medtronic's Evera SureScan implantable ...Learn More
Trial underway for Boston Scientific's defibrillator, pacemaker leads
Boston Scientific announced the first implantation of its Reliance 4-Front defibrillation leads and Acuity X4 pacemaker ...Learn More
Allograft-based wound care device debuting at conference
Alliqua is introducing its human amniotic membrane allograft at a wound care conference this week in Orlando, Fla. ...Learn More
Device tax is a "disincentive to startups," senator says
During a visit Tuesday to Novocure's facility in Portsmouth, N.H., Sen. ...Learn More
FDA clears advanced imaging system from Shimadzu
Shimadzu Medical Systems has been cleared by the FDA to market its Sonialvision G4 system. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
New online, multimedia resource for type 2 diabetes education
Type 2 diabetes is a global epidemic, affecting more than 350 million people worldwide. ...Learn More
I am always ready to learn, although I do not always like being taught.
Winston Churchill, former British prime ...Learn More
Spinal implant firm raises IPO target to about $183M
Virginia-based K2M, which specializes in implantable spinal devices, announced that it could pull in as much as $183 million ...Learn More
Funding round pulls in $30M for Guardant Health
A Series B funding round led by Khosla Ventures has brought in $30 million for Guardant Health, a startup developing ...Learn More
Amendia sells cervical spinal surgery devices to Medline
Amendia has agreed to sell its anterior cervical fusion distraction pin assets to Medline Industries for undisclosed terms. ...Learn More
Partnership aims to speed commercialization of biomedical devices
Ohio's Austen BioInnovation Institute in Akron has entered into a partnership with Nottingham Spirk to help biomedical ...Learn More
EU approves Aperion's bioengineered knee reconstruction device
Aperion Biologics has earned the CE mark to market its Z-Lig ACLR system in Europe. ...Learn More
DOT plans to set up U.S. shop
DOT, a German maker of implant coating technology designed for orthopedic uses, looks to spend $4.5 million to set up its ...Learn More
Study urges feds to promote R&D of cost-effective drugs, devices
A RAND study advises that, in order to drive U.S. ...Learn More
Single-site robotic surgery device from Intuitive wins FDA nod
The FDA has cleared Intuitive Surgical to market its da Vinci Sp technology. ...Learn More
Program aims to expedite FDA approval of certain devices
Certain high-risk medical devices would be eligible for fast-track review under a new program proposed by the FDA. ...Learn More
FDA clears throat infection test from Quidel
Quidel has secured FDA clearance for its Lyra Direct Strep system, a multiplex real-time polymerase chain reaction test that ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
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Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
There are no passengers on Spaceship Earth. We are all crew.
Marshall McLuhan, Canadian ...Learn More
FDA sets review date for ResQCPR resuscitation device
A panel of FDA advisers will meet on May 6 to consider Advanced Circulatory Systems' premarket approval application for its ...Learn More
N.Y. accelerator to invest in medical device, 4 other projects
Five innovative projects related to medical imaging and other areas will receive grants from the State University of New ...Learn More
Firms partner to develop biomarker blood test for A3AR
Smart Assays has agreed to create a test kit that molecular labs can use to determine patients' responses to Can-Fite ...Learn More
Response Genetics agrees to offer lung cancer test panel
Oregon Health & Science University's Knight Diagnostic Laboratories has entered into a marketing deal with Response Genetics ...Learn More
Orthofix names new interim CFO
David Ziegler has been tapped to serve as chief financial officer at Orthofix on an interim basis. ...Learn More
Strong growth forecast for global neurostimulation device market
A BCC Research report predicts that the global market for neurostimulation devices will increase to almost $4.1 billion in ...Learn More
PGXL gains license to offer testing services in Calif.
Kentucky-based PGXL Laboratories has obtained a license to offer its testing services in California. ...Learn More
Highly sensitive DNA tests could improve leukemia treatment, study finds
In a study of 22 patients with cytogenetically normal acute myelogenous leukemia, highly sensitive microarray tests found ...Learn More
RTI announces market release of FDA-cleared spinal device
The Streamline OCT System, which was cleared by the FDA last month, is available commercially, according to RTI Surgical. ...Learn More
2 patents issued to computer-aided detection firm VuCOMP
VuCOMP has received a pair of patents covering its M-Vu CAD mammography system. ...Learn More
AdvaMed launches "Med Tech Minute" video series on the value of medical technology
In the first installment in a new video series on the value of life-changing medical technology, Michael T. ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, Washington, D.C. ...Learn More
We are not makers of history. We are made by history.
Martin Luther King Jr., American civil rights ...Learn More
Medtech sector drew $588M in VC financing in Q1, report says
A PricewaterhouseCoopers and National Venture Capital Association report finds that the life sciences sector raised $1.1 ...Learn More
Series C round pulls in $15M for ForSight Vision5
A Series C funding round has brought in $15 million for ForSight Vision5. ...Learn More
Minn. startup developing diabetes device gets $150K boost
A regulatory filing disclosed that MetaModix has obtained $150,000 in financing from three unnamed backers and hopes to ...Learn More
La. startup wins $72K in prizes for eardrum repair patch
Tympanogen has garnered a total of $72,000 in prizes from Tulane University's Business Model Competition and Rice ...Learn More
FDA, China partner to assure medical products' safety, efficacy
A strong working relationship has been established by the U.S. ...Learn More
Studies show positive results for Medtronic's stent graft
Medtronic reported that its Endurant stent graft, designed to treat abdominal aortic aneurysms, demonstrated positive ...Learn More
OsteoAMP technology shows promising trial results
A study in the Journal of Spine showed positive results for Advanced Biologics' OsteoAMP system, an allograft-based growth ...Learn More
Device to address neuroma formation gets FDA OK
The FDA has cleared Collagen Matrix to market its device designed to manage peripheral nerve injuries in the foot to prevent ...Learn More
Software bug leads Spacelabs to recall certain Arkon devices
A recall initiated by Spacelabs Healthcare involving certain lots of its Arkon anesthesia delivery system has been ...Learn More
Firm sets sights on FDA approval of robotic surgery device
TransEnterix is working to advance its SurgiBot system through the FDA approval process and eventual commercial release of ...Learn More
New online, multimedia resource for type 2 diabetes education
Type 2 diabetes is a global epidemic, affecting more than 350 million people worldwide. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
When all else is lost, the future still remains.
Christian Nestell Bovee, American ...Learn More
IPO could bring in $54M for Vital Therapies
Vital Therapies seeks to obtain $54 million in an initial public offering of 4.5 million company shares valued at $12 each. ...Learn More
Inspiro Medical acquired by Opko Health
Inspiro Medical has been acquired by respiratory drug maker Opko Health for undisclosed terms. ...Learn More
Calif. surgical-device maker seeks $43.9M from stock sale
California-based Cardica hopes to raise $43.9 million through a public stock offering that could be completed next week. ...Learn More
Breast cancer detection device firm advances $10M funding round
First Warning Systems has raised $540,000 of a hoped-for $10 million financing round. ...Learn More
Danaher posts Q1 revenue growth; Culp to step down as CEO
Danaher posted $4.66 billion in revenues during the first quarter, a 5% increase over $4.44 billion during the same period ...Learn More
Calgary Scientific's imaging tool gains Chinese certification
Chinese regulators have certified Calgary Scientific to offer its ResolutionMD system to medical practitioners in China. ...Learn More
China OKs Cepheid's TB and rifampin resistance test
Cepheid has secured clearance to market the Xpert MTB/RIF test, a molecular assay used to diagnose tuberculosis and rifampin ...Learn More
Anika begins U.S. distribution of knee device
Anika Therapeutics has begun U.S. ...Learn More
Covidien's camera-equipped feeding tube gets FDA OK
The FDA has granted Covidien approval for a camera-equipped disposable feeding tube known as Kangaroo with IRIS Technology, ...Learn More
Endo Health unit receives warning letter over issues at Minn. facility
American Medical Systems, a unit of Endo Health, has received an FDA warning letter over procedural issues found at its ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Success is the sum of small efforts repeated day in and day out.
Robert Collier, American ...Learn More
TriVascular Technologies kicks off IPO
On Wednesday, stent-graft-maker TriVascular Technologies launched its initial public offering of 65 million shares valued at ...Learn More
Breast cancer Dx firm obtains $2.7M from investors
A group of backers has pumped $2.7 million into Eventus Diagnostics. ...Learn More
Startup developing mini-laparoscopic tools gets $644K boost
Miret Surgical, a spinoff of Stanford BioDesign, has secured $644,750 in a Series A financing round, said CEO John Avi Roop. ...Learn More
Heart devices helped fuel income growth for St. Jude in Q1
St. ...Learn More
Opko Health rebrands Prolor Biotech
Prolor Biotech has been rebranded by Opko Health as Opko Biologics, with Shai Novick continuing as president. ...Learn More
Firms partner to offer genetic tests in Canadian market
LifeLabs Medical Laboratory Services has entered into a marketing agreement with Contextual Genomics under which the ...Learn More
Wash. firm obtains funds to help launch heart device studies
A funding round has pulled in $20 million for Cardiac Dimensions, maker of the Carillon Mitral Contour System intended to ...Learn More
Ulrich announces U.S. launch of titanium spinal implants
The tezo line of titanium spinal implants is now available commercially in the U.S., according to ulrich medical, which ...Learn More
Device tax slows profitability, stalls acquisitions, execs say
The 2.3% medical device tax may be hindering large medtech firms from investing in merger and acquisition deals, industry ...Learn More
GS1 issues guidelines on unique device ID implementation
Supply chain standards development group GS1 has issued a guidance document meant to help medical device companies use GS1 ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...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
An expert is someone called in at the last minute to share the blame.
Sam Ewing, American writer and ...Learn More
Boston Scientific wins FDA nod for 4 implantable heart devices
Boston Scientific has secured FDA approval for the Inogen Mini and Dynagen Mini implantable cardioverter defibrillators, or ...Learn More
Mainstay eyes $31.7M from IPO; Lombard drops IPO plans
Mainstay Medical, an Irish firm specializing in orthopedic devices, has filed for an initial public offering in Ireland and ...Learn More
Stryker's $172M purchase of Berchtold finalized
Stryker has wrapped up its purchase of Berchtold Holding, a Germany-based maker of surgical-room equipment, for $172 ...Learn More
Opsens renews licensing deal with Abiomed
Opsens has agreed to renew an exclusive licensing deal it struck with Abiomed in 2010. ...Learn More
Vermillion on track to set up clinical reference lab
Vermillion is moving forward with plans to open a clinical reference laboratory after satisfying the necessary regulatory ...Learn More
Canadian medtech license submission forms updated
Health Canada has revised the application documents for sponsors and companies seeking licenses for Class II, III and IV ...Learn More
J&J unit's facility expansion in Ireland could add 420 jobs
Ethicon Biosurgery, a Johnson & Johnson unit specializing in hemostasis and surgical sealant devices, is setting up a ...Learn More
N.Y. state grants clinical lab permit to Almac's Dx unit
The diagnostics division of Almac can now obtain clinical samples from New York after obtaining a clinical laboratory permit ...Learn More
Misonix's ultrasonic surgical tools presented at conference
The BoneScalpel system intended to support fast, accurate and safe osteotomies was unveiled by Misonix at a recent ...Learn More
FDA approves study of Reverse Medical's aneurysm device
The FDA has granted Reverse Medical investigational device exemption approval to conduct clinical studies in the U.S. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
I am more afraid of an army of 100 sheep led by a lion than an army of 100 lions led by a sheep.
Charles Maurice de Talleyrand-Perigord, French ...Learn More
Registry launched to test Boston Scientific's device for Parkinson's
Boston Scientific said the first patient has been enrolled in a registry investigating the use of its Vercise deep brain ...Learn More
Debt funding round brings in $9M for Cerapedics
Cerapedics has secured a loan worth $9 million, part of which will go toward the company's efforts to navigate the U.S. ...Learn More
Wright Medical plans facility expansion in Arlington, Tenn.
Wright Medical, which specializes in extremity medical devices, is adding 52,000 square feet of office and warehouse space ...Learn More
Australia considers changes to device, drug-fee exemption program
The Therapeutic Goods Administration in Australia is seeking comments through May 23 on proposed changes to its low-value ...Learn More
Irish agency enters medtech R&D partnership with Mayo Clinic
The Mayo Clinic has struck a deal with Enterprise Ireland, a business and research-and-development promotion agency, to ...Learn More
Patient enrollment for Rox's hypertension device study completed
Rox Medical has finished enrolling 100 patients in a pivotal clinical study of its Rox Coupler system. ...Learn More
CT system from Toshiba certified for use on Air Force network
The Air Force has granted Toshiba America Medical Systems approval-to-operate status for its CT technology, allowing the ...Learn More
Medicrea's personalized spinal rod system makes EU debut
A spinal osteosynthesis rod system customized to each patient has been released in Europe by Medicrea. ...Learn More
FzioMed gets chance to dispute FDA's prior ruling over spinal surgery gel
FzioMed will meet with an FDA dispute-resolution panel on June 10 to consider its Oxiplex gel, designed to support healing ...Learn More
FDA clears advanced CT technology from GE Healthcare
The FDA has cleared GE Healthcare to market its Revolution system, which could be distributed worldwide starting this ...Learn More
7th Annual FDA/MTLI Medical Device and Diagnostic Statistical Issues Workshop
Tuesday, April 29 – Wednesday, April 30Marriott at Metro Center, 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 easy to sit up and take notice. What is difficult is getting up and taking action.
Al Batt, American ...Learn More
Sante Ventures secures $139M health care investment fund
A regulatory filing disclosed that Sante Ventures has obtained $139 million for its latest investment fund. ...Learn More
Bio-Rad acquires DNA-sequencing technology firm
Bio-Rad Laboratories has agreed to pay an undisclosed sum to acquire GnuBIO, a Massachusetts-based maker of a droplet-based ...Learn More
Qiagen gains exclusive license for blood disorder biomarker
CeMM Vienna has agreed to allow Qiagen to exclusively license its calreticulin biomarker for undisclosed terms. ...Learn More
Koning's breast CT scanner wins approval in Canada
Health Canada has given Koning the go-ahead to market its CT scanner intended for full breast imaging with high contrast and ...Learn More
EU approves wider use of Vexim's spinal device
European regulators have granted Vexim expanded CE mark approval for its SpineJack technology. ...Learn More
Minn. startup raises $25M to further develop mitral valve device
Tendyne Holdings has obtained $25 million in a Series C round of financing led by Apple Tree Partners. ...Learn More
Ortho Development's new hip prosthesis gains FDA clearance
The FDA has granted Ortho Development clearance for its Ovation Tribute Hip Stem. ...Learn More
Advanced diagnostic monitor from NEC lands FDA clearance
The FDA has cleared NEC to market its MultiSync MD302C4 LCD medical monitor, which comes with advanced LED backlighting, a ...Learn More
FDA to meet with Guided Therapeutics over cervical device
The FDA has agreed to meet with Guided Therapeutics to consider the company's renewed bid for approval of its LuViva system ...Learn More
MRI coil from ClearMRI Solutions OK'd by FDA
The Helios-RG8 MRI coil accessory kit, developed by ClearMRI Solutions, has obtained clearance from the FDA. ...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 much easier to be a hero than a gentleman.
Luigi Pirandello, Italian ...Learn More
Covidien pays more than $100M for New Wave Surgical
Covidien has paid more than $100 million to acquire New Wave Surgical, maker of a device used to keep robotic and ...Learn More
Robust growth forecast for U.S. pain management device market
A Decision Resources Group report predicts that by 2022, the U.S. ...Learn More
Former Becton executive takes the helm of CeQur
CeQur, maker of an insulin pump for type 2 diabetes patients, has tapped Douglas Lawrence to serve as its new CEO. ...Learn More
EU approves Seno Medical's breast cancer imaging tool
Seno Medical Instruments has obtained the CE mark for the Imagio opto-acoustic imaging tool, which is used to enhance breast ...Learn More
Abbott wraps up patient enrollment in Absorb device studies
Abbott has finished enrolling some 2,800 patients in three clinical trials evaluating its Absorb system, a dissolving, ...Learn More
10 biventricular pacemakers from Medtronic gain FDA OK for wider use
Medtronic has secured expanded FDA approval for 10 of its biventricular pacemakers -- the Consulta CRT-P and CRT-D, Brava ...Learn More
Spinal surgery device from Baxano lands FDA clearance
The FDA has cleared Baxano Surgical to market the Avance MIS Pedicle Screw System, which is set for full market release ...Learn More
2 cardiac patients in Texas get help with battery-powered device
A subcutaneous internal cardioverter-defibrillator developed by Boston Scientific has brought new hope for Ruben Rivera, a ...Learn More
Wyden urged to join push for device tax repeal
Sen. ...Learn More
FDA approves RevMedX's device to stem internal bleeding
The FDA has granted RevMedX approval to market its XStat system. ...Learn More
Medical Device Reimbursement Workshop
Wednesday, May 7 – Thursday, May 8Westin Long Beach, Long Beach, Calif. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
A good example is far better than a good precept.
Dwight Moody, American preacher and ...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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