Media Contact

News

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

SmartBrief
Danaher to acquire Nobel Biocare for $2.2B
Danaher has agreed to pay about $2.2 billion to purchase Nobel Biocare, a dental-implant maker, in a deal said to be the ...Learn More
$50M shelf registration filed by Vermillion
A shelf registration has been filed by Vermillion with the goal of selling $50 million in stocks or related securities over ...Learn More
From hearts and bones to eyes and ears: VCs shift focus
Venture firms are investing more in treatments for blindness and hearing loss, according to The Wall Street Journal. ...Learn More
InSightec receives $12.5M from Chinese investors
A group of Chinese investors has pumped $12.5 million into InSightec, according to Elbit Medical Technologies, which owns a ...Learn More
Calif. Dx firm sets up shop in Europe
California-based Advanced Cell Diagnostics, which has developed a research-use-only in situ RNA detection test, has ...Learn More
Covidien kicks off embolization, stroke device studies
Covidien has begun patient enrollment in an FDA investigational device exemption trial of its Pipeline system, an ...Learn More
Partnership aims to develop early breast cancer Dx test
U.S.-based OncoCyte and U.K.-based Abcodia are collaborating to create a diagnostic test for early detection of breast ...Learn More
Medtronic announces U.S. release of wireless heart monitor
Medtronic said its SEEQ Mobile Cardiac Telemetry System, which won FDA clearance earlier this year, is available ...Learn More
Device uses magnets to remove toxins from blood
Scientists at the Wyss Institute for Biologically Inspired Engineering in Boston have designed a device inspired by the ...Learn More
U.S., EU regulators OK St. Jude's OCT imaging technology
A device developed by St. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
I have become my own version of an optimist. If I can't make it through one door, I'll go through another door, or I'll make a door. Something terrific will come no matter how dark the present.
Rabindranath Tagore, Indian ...Learn More
Symetis' transfemoral heart valve wins EU approval
Symetis has received the CE mark in Europe for its Acurate neo system, a transcatheter aortic valve implant delivered via a ...Learn More
Report: Ablation tech market could hit $2.41B by 2019
A MarketsandMarkets report predicts that the worldwide market for ablation devices could rise to about $2.41 billion in five ...Learn More
Stock sale could bring in $26.6M for Corindus
Corindus Vascular Robotics, which has operations in the U.S. ...Learn More
Medigus reports MUSE device trial results, wins funds
Medigus has announced that its MUSE, or Medigus Ultrasonic Surgical Endostapler, system demonstrated promising results in a ...Learn More
World's greenest companies include Abbott, Medtronic
Abbott has been recognized by the Dow Jones Sustainability World Index as among the companies with the most environmentally ...Learn More
EU OKs Biocartis' BRAF mutation test, molecular Dx platform
Biocartis has made its BRAF Mutation Test and Idylla molecular diagnostics platform available commercially in Europe, which ...Learn More
Researchers developing electronic skin to find lumps in breasts
A study in the journal ACS Applied Materials and Interfaces found that an electronic skin that is capable of "feeling" and ...Learn More
Beta-O2's artificial pancreas set to undergo clinical trial
Using funding from the Juvenile Diabetes Research Foundation, Beta-O2 is launching a clinical study of its ßAir device, a ...Learn More
Mitsubishi signs radiotherapy tech supply deal
The SAGA Heavy Ion Medical Accelerator in Japan has tapped Mitsubishi Electric to supply it with pencil-beam scanning ...Learn More
FDA clears pedicle screw device from ChoiceSpine
The FDA has given ChoiceSpine 510(k) clearance to market its THUNDERBOLT technology. ...Learn More
Navigating Japan's New Regulatory Reforms
Monday, Dec. 8, to Tuesday, Dec. 9 -- Washington, D.C.Thursday, Dec. 11, to Friday, Dec. 12 – San Francisco, Calif. ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Look for a way to lift someone up. If that's all you do, it's enough.
Elizabeth Lesser, American ...Learn More
Mevion Medical plans to go public to raise $69M
Mevion Medical Systems seeks to obtain $69 million in an initial public offering. ...Learn More
Immunodiagnostic Systems strikes deal to acquire Diametra
Immunodiagnostic Systems has agreed to pay an undisclosed amount to purchase Diametra, an Italian firm specializing in ...Learn More
Wells Fargo provides $2M credit facility to Spine Pain Management
Wells Fargo Bank has granted Spine Pain Management a credit facility worth $2 million. ...Learn More
Former Intuitive Surgical exec takes the helm of MRI Interventions
Frank Grillo has been appointed to serve as CEO of MRI Interventions. ...Learn More
Advanced intraocular lens from AcuFocus gets CE mark
Regulators in Europe have given AcuFocus the CE mark for its IC-8 intraocular lens, designed to treat presbyopia in patients ...Learn More
Abbott unit could open manufacturing plant in Malaysia by 2015
Abbott Medical Optics plans to establish its first manufacturing plant in Malaysia, which company executive Diane Beno said ...Learn More
Device said to diagnose disease in minutes could hit market in 2016
QuantuMDx introduced at TEDMED 2014 a prototype of a device that could be used to spot Ebola, malaria, HIV and other ...Learn More
Wrist-worn device used to detect Parkinson's symptoms
Global Kinetics has received clearance from the FDA for its Personal KinetiGraph device, to be worn on the wrist for ...Learn More
FDA clears balloon catheter from Medtronic
The FDA has given Medtronic 510(k) clearance to market the NC Euphora balloon catheter. ...Learn More
Device used during MRI-based brain surgery wins FDA nod
IMRIS has secured 510(k) clearance from the FDA to market its HFD rocker arm, which is used in conjunction with the firm's ...Learn More
Medical Devices and Products Liability
Wednesday, Nov. 5, to Thursday, Nov. 6AdvaMed Office, Washington, D.C. ...Learn More
Advertising and Promotion of Medical Devices workshop
Tuesday, Nov. 18, to Wednesday, Nov. 19Renaissance Dupont Circle, Washington, D.C. ...Learn More
It doesn't matter where you are coming from. All that matters is where you are going.
Brian Tracy, Canadian ...Learn More
Argon buys maker of soft-tissue biopsy instruments
Argon Medical Devices has agreed to purchase US Biopsy for an undisclosed amount. ...Learn More
Md. mitral heart valve device firm gets $3.2M funding boost
A round of financing led by Epidarex Capital has so far brought in $3.2 million for Harpoon Medical. ...Learn More
Kimberly-Clark gears up for medical-device-unit spinoff
By Nov. 1, Kimberly-Clark will split off its health care unit into a stand-alone entity known as Halyard Health. ...Learn More
Reapplix picks former Acrobot exec to serve as CEO
Graeme Brookes, who formerly led robotic-technology company Acrobot, has been tapped to serve as CEO of Reapplix. ...Learn More
EU, Canadian regulators approve J&J unit's stent graft
Regulators in Canada and Europe have granted Cordis, a Johnson & Johnson unit, the green light to market its Incraft AAA ...Learn More
HART CEO David Green on the transformative potential for regenerative medicine
David Green tells MassDevice.com about the decision to split Harvard Bioscience and Harvard Apparatus Regenerative ...Learn More
U.S. study of Medtronic's repositionable heart valve kicks off
Medtronic has begun patient enrollment in a U.S. ...Learn More
Caprion gets Fox Foundation grant for Parkinson's biomarkers research
The Michael J. ...Learn More
Advanced ultrasound scanner released by Analogic
Analogic said its ultrasound scanner that builds on the firm's TriCore architecture is available commercially in specific ...Learn More
Tyber announces limited launch of trauma screw implant
Tyber Medical is making its headless cannulated trauma screw implant available to surgeon advisers and private-label ...Learn More
FDA clears 2 surgical plating systems from EDGE Orthopaedics
The FDA has cleared EDGE Orthopaedics to market a pair of surgical plating technologies. ...Learn More
Application of Risk Management to Medical Devices: Compliance with ISO 14971
Tuesday, Oct. 28, to Wednesday, Oct. ...Learn More
Mobile Apps and Network-Aware Devices Webinar
Tuesday, Nov. 41:00 p.m. – 2:00 p.m. ...Learn More
From what we get, we can make a living; what we give, however, makes a life.
Arthur Ashe, American professional tennis ...Learn More
Medtech sector a boon for N.Y.'s economy, report says
The medical device industry in New York is booming, providing more than 74,000 jobs statewide, with around 28,500 of them in ...Learn More
Opticul Diagnostics to receive $450K investment from BATM
Israeli firm BATM Advanced Communications has agreed to acquire a 20% stake in Opticul Diagnostics for as much as $450,000 ...Learn More
Mich. awards $300K in training grant to Orchid Orthopedic
Orchid Orthopedic Solutions, which develops orthopedic implants and surgical instruments, has been awarded a grant worth ...Learn More
Maker of osteoporosis Dx device wins innovation award
Bone Index is among this year's recipients of the Nordic Stars Award, which was presented at the recent Nordic Life Science ...Learn More
China OKs robotic surgery device from Mazor
Mazor Robotics has received the green light in China to market its Renaissance system, a robot-assisted surgery device used ...Learn More
Hamilton gets CE mark for transport ventilator with neonatal option
The HAMILTON-T1 transport ventilator, which incorporates neonatal functionality, has obtained CE mark approval in Europe. ...Learn More
Biodesix wins reimbursement coverage for lung cancer assay
Highmark has agreed to provide reimbursement coverage for Biodesix's VeriStrat assay. ...Learn More
Titan Spine offers warranty for spinal fusion devices
Titan Spine has issued a new warranty covering its Endoskeleton interbody fusion systems. ...Learn More
New test detects antibiotic-resistant infections in hours
Oregon State Public Health Laboratory researchers have designed the Carba NP test to detect carbapenem-resistant ...Learn More
FDA's plan to regulate LDTs undergoes congressional scrutiny
A hearing held Tuesday by a House subcommittee focused on the FDA's proposal to subject lab-developed tests to regulatory ...Learn More
For more:
AdvaMedDx Executive Director Andrew Fish testified before a House subcommittee Tuesday in support of FDA regulation of ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Talent is God-given; be humble. Fame is man-given; be thankful. Conceit is self-given; be careful.
John Wooden, American basketball ...Learn More
Coronary-stent manufacturer obtains $20M in financing
A funding round has pulled in $20 million for Tryton Medical, which specializes in stents used to treat patients with ...Learn More
Breas expands ventilator offering with B&D Electromedical buy
Breas Medical has struck a deal to acquire the U.K.'s only ventilator manufacturer, B&D Electromedical, for an undisclosed ...Learn More
Former QSpine exec named U.K. sales manager of Aurora Spine
Mike Coupland has been appointed to serve as national sales manager for Aurora Spine's operations in the U.K. ...Learn More
Codman Neuro scores regulatory wins in Asia-Pacific region
Codman Neuro, a unit of Johnson & Johnson's DePuy Synthes business, has received the go-ahead to market its Revive SE device ...Learn More
Study: Patch with microscopic vaccination needles painless, effective
Researchers in Cork, Ireland, have developed a vaccination technique that uses a small patch with about 100 microscopic ...Learn More
GenetWorx gains OK to offer drug-response test panel in N.Y.
New York has certified GenetWorx to offer genetic testing services using its DNA Drug-Response Panel to in-state patients. ...Learn More
Diagnostic tool designed to ID cancer in blood samples
Exosome Sciences and its parent company, Aethlon Medical, have created a diagnostic tool that they say could spot several ...Learn More
Device to stop bleeding during GI endoscopies hits U.S. market
Olympus is making its QuickClip Pro system available commercially in the U.S., which comes on the heels of an FDA clearance ...Learn More
FDA grants orphan drug designation for HART-Trachea
Harvard Apparatus Regenerative Technology has received orphan drug designation from the FDA for its HART-Trachea, a ...Learn More
New patent issued to Ceterix Orthopaedics
Ceterix Orthopaedics has expanded its patent portfolio with one that covers its methods and technologies, including the ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
I must govern the clock -- not be governed by it.
Golda Meir, former Israeli prime ...Learn More
Recalls of medical devices declined dramatically in Q2, report says
A Stericycle report found that during the second quarter, the industry saw 275 medical device recalls affecting 148 firms, ...Learn More
Mass. maker of type 2 diabetes device obtains $40M
A Series C financing round headed by Mithril Capital Management has brought in $40 million for Fractyl Laboratories. ...Learn More
Md. migraine-device firm advances $6.6M funding round
ENeura has secured $5.8 million from 67 backers, bringing the company closer to its financing target of $6.6 million. ...Learn More
Stock offering brings in $3M for Integrity Applications
A private shares offering has pulled in $3 million for Integrity Applications. ...Learn More
Ariz. molecular Dx firm eyes $800K from stock sale
A regulatory filing shows that HTG Molecular Diagnostics looks to obtain $800,000 in a private shares offering that ...Learn More
Japanese firm unveils 2 advanced imaging monitors
Japan-based Totoku has introduced the CCL210 and CCL242 monitors, the latest addition to its i2 product line. ...Learn More
Study shows positive results for Biotronik's drug-eluting stent
A clinical study appearing in The Lancet found that Biotronik's Orsiro biodegradable polymer-based stent, which releases the ...Learn More
Acute-kidney-injury test from Astute Medical gets FDA OK
The FDA has given Astute Medical the go-ahead to market its NephroCheck test under the agency's de novo premarket review ...Learn More
FDA approval sought by Cerapedics for i-FACTOR bone graft
Cerapedics has submitted to the FDA an application seeking premarket approval for the i-FACTOR Peptide Enhanced Bone Graft. ...Learn More
APEX Medical, ResMed reach patent settlement deal
APEX Medical and ResMed have agreed to settle a patent dispute for undisclosed terms. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Progress is impossible without change, and those who cannot change their minds cannot change anything.
George Bernard Shaw, Irish ...Learn More
Avedro expands corneal device footprint with Iroc Innocross buy
Avedro has agreed to pay an undisclosed sum to acquire Iroc Innocross, the Swiss maker of a cross-linking device used to ...Learn More
Veracyte enters lung cancer Dx market with Allegro acquisition
Veracyte has agreed to pay $21 million in cash and company stock to buy Allegro Diagnostics, which has developed a gene ...Learn More
Sengenics signs prenatal test distribution deal with Sequenom
Sengenics has agreed to bring Sequenom's VisibiliT assay to Indonesia, Thailand and Brunei under an exclusive deal reached ...Learn More
Industry veteran named consumer GM at NeuroMetrix
Frank McGillin, who previously worked at Johnson & Johnson and Philips Oral Healthcare, has been selected to serve as senior ...Learn More
EU grants CE mark for Cepheid's trichomoniasis test
The Xpert TV trichomoniasis test has obtained CE mark approval in Europe, according to Cepheid, which developed the ...Learn More
Amoy Diagnostics wins approval for 2 IVD kits in China
Amoy Diagnostics has been granted approval to market its AmoyDx ROS1 and AmoyDx ALK/ROS1 in vitro diagnostic test kits in ...Learn More
Trial enrollment for Claret's cerebral protection device completed
Claret Medical has completed patient enrollment in a U.S. ...Learn More
Ultrasound scanner from Esaote scores FDA clearance
The FDA has cleared Esaote North America to market its MyLab Six ultrasound technology for use in general, cardiovascular, ...Learn More
Stereotaxis receives FDA clearance for catheter device
The FDA has granted Stereotaxis 510(k) clearance to market its Vdrive robotic navigation system with V-Loop variable loop ...Learn More
FDA OKs tinnitus device from Otoharmonics
Otoharmonics has been cleared by the FDA to market its Levo System, designed to provide temporary relief for patients with ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Without a humble but reasonable confidence in your own powers you cannot be successful or happy.
Norman Vincent Peale, American minister and ...Learn More
Medtronic's next-gen heart valve gains approval in Europe
Medtronic has received CE mark approval to market its CoreValve Evolut R system in Europe. ...Learn More
Calif. maker of presbyopia device obtains $21M
California-based AcuFocus has secured $21 million in a round of financing from existing investors, including Medtronic. ...Learn More
Impedimed scores reimbursement win for lymphoedema Dx device
The American Medical Association has issued a code expanding reimbursement coverage for Impedimed's device used to detect ...Learn More
BSD Medical closes hyperthermia-device deal with Linden Bioscience
Linden Bioscience has purchased another BSD-2000 hyperthermia device from BSD Medical, the fourth such purchase made by the ...Learn More
EU approves Abbott's wearable blood glucose monitor
Abbott has earned the CE mark in Europe for its FreeStyle Libre system, a wearable device that can monitor blood glucose ...Learn More
Roche earns CE mark for blood and plasma donor screening systems
Roche has obtained the CE mark for its cobas 6800/8800 systems, two fully automated molecular testing systems for blood and ...Learn More
Medtech trends: The most talked-about device makers in August 2014
MassDevice.com looks at the Internet chatter surrounding the medical device industry with some of the most searched-for ...Learn More
Scientists develop rapid, low-cost test for sickle cell disease
Harvard University researchers have designed a faster and less-expensive test for detecting sickle cell disease that can ...Learn More
Hip replacement device from Ortho Development wins FDA nod
The FDA has given Ortho Development 510(k) clearance to market its Alpine system for use during total hip arthroplasty and ...Learn More
FDA urged to improve role of medtech registries in U.S.
Several groups are calling on the FDA to spur the development of registries to monitor medical devices. ...Learn More
U.S., EU regulators OK K2M's MESA Hooks system
The FDA has cleared K2M to market its MESA Hooks technology, designed to offer a low-profile implant option to the company's ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Life is not a matter of holding good cards, but of playing a poor hand well.
Robert Louis Stevenson, Scottish ...Learn More
Boston Scientific wraps up $415M purchase of Bayer Interventional
The acquisition of Bayer Interventional by Boston Scientific for $415 million has been finalized. ...Learn More
Invacare agrees to $23M sale of Altimate Medical business
Invacare has agreed to sell its Altimate Medical unit, which develops standing-assistance devices for patient ...Learn More
Former ArthroCare exec takes the helm of Bluegrass Vascular
Gabriele Niederauer, who most recently served as vice president of research and development at ArthroCare's ENT-Sinus unit, ...Learn More
EU approves influenza, RSV test from Cepheid
Cepheid has earned the CE mark to market its Xpert Flu/RSV XC test in Europe. ...Learn More
Cancer Genetics wins CE mark for cervical cancer test
European regulators have granted Cancer Genetics the CE mark, allowing the firm to market its FISH-based HPV-associated ...Learn More
St. Jude's FFR tech shows promise in coronary artery disease trial
A study in the New England Journal of Medicine showed promising results for St. ...Learn More
Advanced Biological enters Dx development deal with Mayo Medical
Advanced Biological Laboratories has agreed to work with Mayo Medical Laboratories to create next-generation sequencing ...Learn More
Expert creates prototype of a batteryless pacemaker
A Swiss scientist has developed a prototype of a cardiac pacemaker that can operate without the need for batteries. ...Learn More
FDA OKs 3D breast imaging device from GE Healthcare
The FDA has given GE Healthcare approval to market its SenoClaire system, a digital breast tomosynthesis system that ...Learn More
Bunion correction device from Arthrosurface gains FDA clearance
The FDA has cleared Arthrosurface to market its KISSloc Suture System, a tiny plate and suture implant designed to treat ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
The art of being wise is the art of knowing what to overlook.
William James, American philosopher and ...Learn More
Calif. neurostimulation device firm eyes $50M in IPO
NeuroSigma is looking to obtain $50 million in an initial public offering. ...Learn More
$100M shelf registration filed by NanoString Technologies
A shelf registration has been filed by NanoString Technologies with the intent of selling $100 million in stocks or related ...Learn More
Diagnostic test-maker bought by Orgentec for about $16M
Orgentec Diagnostika agreed to pay approximately $16 million to purchase Corgenix Medical, a Broomfield, Colo.-based firm ...Learn More
Debt funding round brings in up to $16M for HTG Molecular
Silicon Valley Bank and Oxford Finance have granted HTG Molecular Diagnostics a loan worth as much as $16 million. ...Learn More
Medtech consultancy firm to set up office, hire 30 in Boston
Regulatory and Quality Solutions, which provides consultancy services to medical device-makers, has announced plans to set ...Learn More
Comments sought for Brazil's device, drug trial proposal
Anvisa, Brazil's medtech regulator, has issued a draft document outlining the agency's new requirements and procedures for ...Learn More
Pentagon awards $255M medical-supply contract to Arthrex
The Department of Defense has awarded Arthrex a contract to supply the department's military units and federal civilian ...Learn More
Clinical trial begins for Kona Medical's hypertension device
Kona Medical has initiated a clinical study evaluating its Surround Sound system, an ultrasound-based renal denervation ...Learn More
Advanced finger pulse oximeter from Nonin gets FDA OK
The FDA has given Nonin Medical 510(k) clearance for its finger pulse oximeter that incorporates the company's PureSAT ...Learn More
FDA OKs CorMatrix's porcine tissue-based surgical envelope
CorMatrix said its CanGaroo ECM Envelope, a pig tissue-derived cellular matrix designed to secure pacemakers and other ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
No matter how busy you are, you must take time to make the other person feel important.
Mary Kay Ash, American ...Learn More
Covidien makes 2nd acquisition this month
Covidien has signed a deal to acquire Sapheon, along with its VenaSeal system used to treat chronic venous insufficiency and ...Learn More
Surgical Frontiers to pump $7M into surgical device startups
Surgical Frontiers has raised an investment fund worth $7 million. ...Learn More
Varian's facility expansion could add 1K jobs in Utah over 20 years
Varian Medical Systems is adding 135,000 square feet of space to its facility in Salt Lake City, where the company ...Learn More
Pacific Edge enters partnership for bladder cancer Dx study
The Southern California Permanente Medical Group has agreed to work with Pacific Edge to investigate the latter's Cxbladder ...Learn More
Industry veteran tapped to lead St. Teresa Medical's clinical affairs
St. Teresa Medical has tapped Rudy Padua, a medtech industry veteran, to serve as its clinical affairs director. ...Learn More
Masimo gains OK for infant hemoglobin monitor in Europe, Japan
Masimo has received approval to market its rainbow DCI-mini system in Europe and Japan, and is preparing for a limited ...Learn More
Postmarket trial of Medtronic's AdaptivCRT algorithm kicks off
Medtronic has initiated a postmarket trial evaluating its AdaptivCRT algorithm, designed to allow cardiac resynchronization ...Learn More
Vital Connect's biosensor patch gets FDA OK for in-home use as patient monitor
The FDA has cleared Vital Connect to market its HealthPatch MD system for in-home use to monitor patients who have just been ...Learn More
Pediatric scoliosis device from Medtronic wins FDA nod
The FDA has cleared Medtronic to market its SHILLA Growth Guidance System, designed to offer a better alternative to ...Learn More
FDA clears veno-venous cannula from CardiacAssist
CardiacAssist has been cleared by the FDA to market its PROTEK Duo system, a veno-venous cannula used during extracorporeal ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
SmartBrief will not publish Monday
In observance of Labor Day in the U.S., AdvaMed SmartBrief will not publish Monday. Publication will resume ...Learn More
A hero is one who knows how to hang on one minute longer.
Novalis, German ...Learn More
Medtronic continues acquisition trail with NGC Medical buy
Medtronic has acquired NGC Medical, an Italian firm that manages intensive care units, operating rooms and cardiovascular ...Learn More
Ill. maker of esophageal cooling device closes $1.5M round
A Series A round of financing has pulled in $1.5 million for Illinois-based Advanced Cooling Therapy, which is preparing to ...Learn More
Calif. molecular Dx firm boosts revenue in Q2
California-based CareDx generated $6.8 million in revenue during the second quarter, up from $5.5 million during the same ...Learn More
Q3 revenue for BioReference Laboratories hits record high
BioReference Laboratories said its revenue hit a record high in the third quarter, generating $222.1 million during the ...Learn More
S. Korean firm to make Ebola virus test kit available in Africa
A molecular diagnostic kit that can spot an Ebola virus subtype tied to recent outbreaks in Africa will be released by ...Learn More
Metastatic brain cancer patient in Israel treated with Brainlab's tech
A 62-year-old patient in Israel has been treated for metastatic brain cancer using Brainlab's Automatic Brain Metastases ...Learn More
Wound care by the numbers: Q&A with Alliqua CEO Dave Johnson
Medtech veteran Dave Johnson has been with Alliqua Biomedical for less than two years, during which time he's overseen a ...Learn More
Serum-based test for preeclampsia in the works
Carmenta Bioscience, a spinoff of Stanford University, is working on a serum-based test that can be used to detect ...Learn More
Brain aneurysm device from MicroVention wins FDA nod
MicroVention, a Terumo unit, has received FDA approval to market its Low-Profile Visualized Intraluminal Support Device. ...Learn More
FDA OKs Hansen Medical's robotic arm transport technology
Hansen Medical has been cleared by the FDA to market its Magellan Transport System, which could hit the market in the third ...Learn More
FDA clears St. Jude Medical's neuromodulation facility in Texas
The FDA has cleared St. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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
Believe you can and you're halfway there.
Theodore Roosevelt, 26th U.S. ...Learn More
Medtronic pays $200M for deep brain stimulation device firm
Medtronic has struck a deal to acquire Sapiens Steering Brain Stimulation, a Dutch company developing a next-generation ...Learn More
Tenn. catheter device firm pushes cap on Series B funding round
Advanced Catheter Therapies has increased the financing target of its Series B round from $3 million to $4.5 million. ...Learn More
Mass. vaccine delivery device maker wins Technology Pioneer award
The World Economic Forum has named Vaxxas as one of this year's recipients of the 2015 Technology Pioneer award. ...Learn More
Amedica appoints new board chairman
Dr. B. ...Learn More
Expanding Orthopedics reports first use of FLXfit system in France
A doctor in France has carried out the first spinal procedure using Expanding Orthopedics' FLXfit system, which was cleared ...Learn More
Asuragen signs cancer panel deal with Janssen Diagnostics
Asuragen has agreed to make its SuraSeq next-generation sequencing cancer panels available to Janssen Diagnostics' customers ...Learn More
Smartphone-based device monitors glaucoma
Israeli researchers have created an implantable sensor that uses a smartphone camera to measure pressure in the eyes of ...Learn More
3D-printed implant restores neck mobility in Chinese boy with vertebral tumor
A 12-year-old boy in China who suffered a spinal cord injury and later developed a vertebral tumor regained motion in his ...Learn More
FDA panel to take another look at Boston Scientific's stroke device
A panel of FDA advisers will convene on Oct. ...Learn More
MR systems from Toshiba certified for use on Air Force Network
The Air Force has granted Toshiba America Medical Systems approval-to-operate status for its Vantage Titan 3- and 1.5-Tesla ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Management is doing things right; leadership is doing the right things.
Peter Drucker, Austrian-American writer and management ...Learn More
Medtronic gains FDA approval for personalized pacemaker
The FDA has granted Medtronic approval to market its Viva CRT-P system for use in treating patients with heart failure or ...Learn More
Mass. senior care tech firm obtains $10M in fresh capital
Healthsense, which develops remote monitoring devices for senior care, has secured $10 million in its latest funding round. ...Learn More
Affymetrix taps Greenwood Genetic Center to offer CytoScan Dx test
Affymetrix has agreed to allow Greenwood Genetic Center to offer its CytoScan Dx Assay, which was cleared by the FDA earlier ...Learn More
Exact Sciences' colorectal cancer test to be offered by Mayo Clinic
Exact Sciences has announced that its Cologuard test, which received approval from the FDA earlier this month, will be ...Learn More
Medtech sector struggling to adopt digital technology, report finds
The medical device industry appears to be lagging behind other sectors in terms of digital technology adoption, according to ...Learn More
EU updates CE mark for Kips Bay Medical's surgical mesh
European regulators have revised the CE mark approval of Kips Bay Medical's eSVS Mesh system. ...Learn More
Global market for advanced orthopedic tech could hit $42.2B in 5 years
The worldwide market for advanced orthopedic systems rose to about $36.4 billion this year and is likely to grow to $42.2 ...Learn More
Device could remove need for open-heart procedures
Irish and U.S. researchers have created a device that they say could eliminate the need for open-heart procedures. ...Learn More
Aura sleep-assist system from Withings hits market
Withings said its Aura system, which uses a sensor to monitor movement, breathing and heart rate while the person is asleep, ...Learn More
FDA clears 2 blood glucose monitors from Nipro
The FDA has cleared Nipro Diagnostics to market its True Metrix Pro and True Metrix self-monitoring blood glucose systems, ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
The pessimist complains about the wind; the optimist expects it to change; the realist adjusts the sails.
William Arthur Ward, American ...Learn More
Covidien boosts vascular tech offering with Reverse Medical buy
Covidien has agreed to pay an undisclosed sum to purchase Reverse Medical, along with its vascular device portfolio. ...Learn More
Fla. cancer genetic testing firm raises $34.6M from stock sale
Florida-based NeoGenomics, which specializes in cancer genetic screening services, has obtained net proceeds of $34.6 ...Learn More
Corgenix signs companion Dx development deal with Eli Lilly
Regulatory filings indicate that Colorado-based Corgenix Medical, which specializes in deadly-virus-detection tests, has ...Learn More
French government awards eye implant contract to Second Sight
The French Ministry of Health has awarded Second Sight Medical a financial contract to provide its Argus II retinal implant ...Learn More
Canada OKs IMRIS' surgical theater with advanced MRI
Health Canada has given IMRIS the go-ahead to market its Visius surgical theater incorporated with an advanced version of ...Learn More
Turkey approves VuCOMP's breast cancer detection software
Turkish regulators have given VuCOMP the green light to sell its M-Vu Breast Density software and M-Vu CAD tools in that ...Learn More
Report: Orthopedic-instrument market poised for more growth in China
A report from Research in China predicts continued growth for the Chinese market for orthopedic instruments, which is ...Learn More
Claret Medical obtains $18 million for development of blood filter
Claret Medical has raised $18 million in a Series B funding round. ...Learn More
Ceiling-mounted DR tube introduced by Carestream
A ceiling-mounted tube option is being offered by Carestream Health for its DRX-Ascend digital radiography technology. ...Learn More
Senator calls for eliminating device tax amid collection difficulties
A Treasury Department report citing issues with collection of the medical device tax is another example of problems with the ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Don't be afraid to give up the good to go for the great.
John D. Rockefeller, American ...Learn More
New size of Direct Flow Medical's TAVI device gains CE mark
European regulators have granted Direct Flow Medical the CE mark for a 23-millimeter size of its transcatheter aortic valve ...Learn More
Prostate cancer test boosts first half 2014 revenue for MDxHealth
Belgium-based molecular diagnostics company MDxHealth generated $4.8 million in revenue during the first half of this year, ...Learn More
Baxter's facility expansion in Ala. could create 200 jobs
Baxter International is investing $300 million to add 230,000 square feet of space to its manufacturing facility in Opelika, ...Learn More
EU notified body plans program of surprise audits
As many as 300 unannounced audits of medical device manufacturers around the world are being planned by BSI Group, and a ...Learn More
Covidien sets up training facility in Brazil
Covidien has announced the opening of its 3,000-square-meter training facility in Sao Paulo, Brazil. ...Learn More
Implantable tissue scaffolds stimulate bone growth
Massachusetts Institute of Technology researchers are developing a bone repair scaffold that releases embedded growth ...Learn More
Sedia Biosciences receives NIH grant for rapid HIV-1 test
The National Institutes of Health's National Institute of Allergy and Infectious Diseases has awarded Sedia Biosciences a ...Learn More
A-fib algorithm used with AliveCor's smartphone ECG wins FDA nod
The FDA has given AliveCor 510(k) clearance to market an algorithm that can accurately identify the presence of atrial ...Learn More
Covidien gets FDA OK for changes to PTFE coating production process
Changes made by Covidien to its polytetrafluoroethylene coating production process have been approved by the FDA. ...Learn More
FDA OKs Philips' 3D planning tool for TAVI procedures
The FDA has cleared Philips Healthcare to market its 3D planning application, designed to help surgeons perform ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Discussion is an exchange of knowledge; argument an exchange of ignorance.
Robert Quillen, American ...Learn More
Pilot initiative will test tools for streamlining medtech regulatory processes
The FDA has released guidelines governing its pilot program to develop tools for streamlining the premarket review and ...Learn More
Dx services boost revenue for Source BioScience in first half of 2014
Source BioScience posted $21.3 million in revenues during the first half of this year, up 46% over the same period last ...Learn More
Hologic tapped to offer fracture evaluation tool in Canada, U.S.
Hologic has agreed to market in the U.S. ...Learn More
Antibacterial gel could eliminate resistant superbugs
A new antibacterial gel composed of peptides has shown promise in killing drug-resistant bacteria including Pseudomonas ...Learn More
Device helps uncover how malaria parasites invade red blood cells
Wellcome Trust Sanger Institute scientists used laser optical tweezers to better understand malaria's invasion of red blood ...Learn More
Kronus' autoantibody test for type 1 diabetes OK'd by FDA
Kronus has received FDA clearance to market its Zinc Transporter 8 Autoantibody test, which can differentiate between type 1 ...Learn More
Study shows faster FDA premarket device approvals this year
An Evaluate Group study found that the number of first-time premarket approvals issued by the FDA rose from nine during the ...Learn More
IRS struggling with medical-device tax under Affordable Care Act
The medical-device tax that is part of the Affordable Care Act is only raising 75% of expected revenue, in part because the ...Learn More
Intraocular lenses to get year reprieve for UDI compliance
Companies developing Class III intraocular and contact lenses have until Sept. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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
Be a yardstick of quality. Some people aren't used to an environment where excellence is expected.
Steve Jobs, American ...Learn More
VC firm to pump $110M into medtech, other health care firms
HealthQuest Capital has secured an investment fund worth $110 million. ...Learn More
Boston Scientific signs development deal with Asahi
Asahi Intecc in Japan has agreed to work with Boston Scientific to create enhanced fractional flow reserve wires that will ...Learn More
Roche signs epigenomic analysis tech deal with Garvan Institute
Roche has entered into a two-year deal with the Garvan Institute of Medical Research to jointly develop new technologies for ...Learn More
Nirmidas moves to commercialize fluorescence technology
Nirmidas Biotech has assembled $2 million for the commercialization of its fluorescence system for improved biomarker ...Learn More
Medtech applications relying on 8 EU notified bodies subject to audit in Australia
Lack of confidence in eight European medical device notified bodies has caused Australia's Therapeutic Goods Administration ...Learn More
Firm to advance lung cancer test in China with fresh capital
20/20 GeneSystems has received an undisclosed investment from BHC Center of Financial and Investment Business. ...Learn More
Remote monitoring outperforms usual care in HF patients
Data on heart failure patients showed that those who used Biotronik's Home Monitoring system for implantable ...Learn More
Device to treat temporomandibular joint pain gets FDA OK
The FDA has cleared TMJ Health to market a device that offers a better alternative to bite splints in treating ...Learn More
FDA clears 3D-printed facial implant
The FDA cleared Oxford Performance Materials' OsteoFab 3D-printed facial implant, which will be distributed globally by ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Most people say that it is the intellect which makes a great scientist. They are wrong: It is character.
Albert Einstein, German-American theoretical ...Learn More
LeMaitre hopes to boost vascular portfolio with Xenotis buy
LeMaitre Vascular has agreed to pay $7.7 million to acquire Xenotis, along with its Omniflow II biological graft. ...Learn More
Partners sought by ElectroCore to advance migraine tech to market
Piper Jaffray has been enlisted by ElectroCore to help the company find possible partners to bring its noninvasive vagus ...Learn More
Cancer Genetics closes $1.9M purchase of BioServe
Cancer Genetics has wrapped up its purchase of BioServe Biotechnologies, an India-based company providing next-generation ...Learn More
OsteoMed signs spinal device co-marketing deal with MedCom
OsteoMed and MedCom Advisors have agreed to jointly distribute OsteoMed's PrimaLOK SP Interspinous Fusion System as well as ...Learn More
Global orthopedic trauma fixation market could hit $9.4B in 6 years
A report from Persistence Market Research forecasts that the worldwide market for orthopedic trauma fixation systems could ...Learn More
Ultrasound scanner with dual probe released by GE
An advanced model of the Vscan ultrasound scanner has been introduced by GE Healthcare. ...Learn More
Image denoising software lands FDA clearance
The FDA has cleared Vital Images to market its Structure Preserving Diffusion software, a postprocessing filter used with ...Learn More
TAVI device used for first time in tricuspid valve replacement in U.S.
A patient with a failing tricuspid valve in her heart was turned down by one surgery center and told by another that she ...Learn More
CMS to hold back a third of data from Sunshine Act site due to inconsistencies
CMS spokesman Aaron Albright said by e-mail that the agency will withhold one-third of the data on payments from ...Learn More
FDA OKs Philosys' smartphone-based blood glucose monitor
The Gmate Smart Blood Glucose Monitoring System, developed by Philosys, has obtained 510(k) clearance from the FDA. ...Learn More
Download new tool kit: The Value of Medical Technology to Treat Cataracts
24.5 million Americans suffer from cataracts, a disease that significantly impairs vision and quality of life, and drives up ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
A good head and a good heart are always a formidable combination.
Nelson Mandela, former South African ...Learn More
Pentagon taps Abbott to develop TBI detection system in $19.5M deal
The Defense Department has awarded Abbott a $19.5 million contract to develop technology that could aid in the detection of ...Learn More
Stock sale could bring in $32.2M for NeoGenomics
NeoGenomics, which specializes in genetic testing, hopes to secure $32.2 million in an offering of company shares valued at ...Learn More
Industry veteran named sales and marketing VP at Volpara
Volpara Solutions, which develops breast imaging technology, has tapped Shawl Lobree to serve as vice president of its ...Learn More
Forum finalizes e-submission rules for IVDs, non-IVD devices
The International Medical Device Regulators Forum has issued final guidelines governing the electronic submission of ...Learn More
China proposes use of generic names for medical devices
A draft rule issued by the China Food and Drug Administration would prohibit the use of personal, company or brand names to ...Learn More
Cook Medical proceeds with study of peripheral stent in China
Cook Medical has begun patient enrollment for a clinical study in China of its Zilver PTX device, a drug-eluting stent used ...Learn More
Field trials underway for multifunctional diagnostic device
U.S. ...Learn More
Siemens' advanced image reconstruction tool gains FDA OK
A third-generation version of Siemens Healthcare's advanced modeled iterative reconstruction, or ADMIRE, software has won ...Learn More
BioTime lands FDA clearance for wound-healing gel
BioTime has been cleared by the FDA to market its Premvia HyStem hydrogel, designed to promote wound healing by ...Learn More
FDA warns Masimo over manufacturing practices at Calif. plant
The FDA has issued a warning letter to Masimo over manufacturing practice violations at its facility in Irvine, Calif. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Love involves a peculiar unfathomable combination of understanding and misunderstanding.
Diane Arbus, American photographer and ...Learn More
FDA offers guidelines on device ID rule, de novo review process
The FDA has released its final guidelines on how small firms may satisfy the unique device identifier rules, including ...Learn More
Silk Road Medical gets $15M boost for stroke prevention device
California-based Silk Road Medical has obtained $15 million in a funding round aiming for $22.5 million. ...Learn More
Interpace Diagnostics buys 2 microRNA tests from Asuragen
Interpace Diagnostics, a unit of PDI, has agreed to acquire Asuragen's miRInform Pancreas and Thyroid cancer tests for $8 ...Learn More
JenaValve picks former Edwards, Endologix exec as CTO
Stefan Schreck has been selected to serve as the new chief technology officer of JenaValve. ...Learn More
AdvancedCath sets up shop in Costa Rica
AdvancedCath has announced the launch of its 20,000-square-foot manufacturing plant in Costa Rica. ...Learn More
Irish Dx firm gains rights to Eiken's LAMP technology
Ireland-based HiberGene Diagnostics has entered into a licensing deal with Eiken Chemical for undisclosed terms. ...Learn More
Study: Hydrogel shows promise in preventing transplant rejection
U.S. ...Learn More
Blood test can detect mutations that cause malaria resistance
A study in The New England Journal of Medicine that examined blood samples of 1,240 people being treated for malaria in ...Learn More
2 wireless detectors unveiled by Rayence
Rayence has introduced a pair of wireless flat-panel detectors tailored for portable or in-room use. ...Learn More
Guidelines on home-use device development finalized by FDA
Final guidance issued by the FDA details the considerations for developing medical devices intended for in-home use by ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Everything that irritates us about others can lead us to an understanding of ourselves.
Carl Jung, Swiss ...Learn More
Second Sight Medical plans to go public to raise $32M
Second Sight Medical, maker of the Argus II eye implant designed to treat blindness in patients with retinitis pigmentosa, ...Learn More
Texas oncology firm obtains $11.8M in Series E financing
A Series E round of financing has pulled in $11.8 million for Castle Biosciences. ...Learn More
Proteocyte gets $554K in funding to boost sales of oral cancer test
A funding round has brought in $554,000 for Proteocyte Diagnostics, a Canadian firm specializing in molecular diagnostic ...Learn More
FirstVitals CMO named to Bacterin's board
Dr. David Goodman has been appointed to serve on the board of Bacterin International Holdings. ...Learn More
Scienion taps RayBiotech to bring its dispensing tools to China
RayBiotech has entered into a distribution deal with German firm Scienion for undisclosed terms. ...Learn More
Japan grants patents to IMRIS' intraoperative MRI tech
The Japan Patent Office has granted IMRIS three patents related to its intraoperative MRI technology integrated with the ...Learn More
CardioMEMS' 11-year payoff worth the wait for Boston Millennia Partners
Boston Millennia's managing general partner Dana Callow discusses the 11-year journey to bring CardioMEMs implantable heart ...Learn More
Exactech reports first use of femoral stem implant
A surgeon at Franciscan St. ...Learn More
Scientists create implantable device that produces insulin
Swiss scientists have created an implantable molecular device that features a sensor that measures blood pH levels and a ...Learn More
Mhealth app developer to seek FDA clearance for SnoreSounds
Appian Medical said it aims to secure 510(k) clearance from the FDA for its sleep apnea application called SnoreSounds and ...Learn More
Medtronic MiniMed reaches settlement deal with J&J unit
Johnson & Johnson has agreed to settle for undisclosed terms a patent lawsuit filed against its Animas division by Medtronic ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
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
Defeat is not the worst of failures. Not to have tried is the true failure.
George Woodberry, American literary ...Learn More
Greatbatch to boost innovation efforts with CCC Medical buy
Greatbatch Medical has agreed to purchase CCC Medical Devices, a Uruguay-based company that develops implantable pulse ...Learn More
Investors pump $59M into Oxford Nanopore Technologies
A round of financing from current and new investors has brought in $59 million for Oxford Nanopore Technologies. ...Learn More
Seventh Sense gets $16M to develop painless blood-collection device
Cambridge, Mass.-based startup Seventh Sense Biosystems has received $16 million in new financing from a Series B funding ...Learn More
Ultrasound systems help fuel Q2 revenue growth for Mindray
Mindray Medical International posted $334.5 million in net revenue during the second quarter, an increase over $307.2 ...Learn More
Former JenaValve exec joins HeartWare as CMO
Dr. Katrin Leadley has been tapped to succeed Dr. David Hathaway as chief medical officer of HeartWare International. ...Learn More
Canada, Singapore OK molecular tests from IMDx
IMDx has received the go-ahead in Canada to market its test that can detect influenza A and B strains and the respiratory ...Learn More
ViaCyte raises $5.4 million to develop artificial pancreas
San Diego-based ViaCyte has received $5.4 million in private equity financing that will be used to support the clinical ...Learn More
Biodegradable wound dressing conforms to irregular shapes, seals out bacteria
Scientists at Tokai University in Japan have developed a nanosheet dressing made from biodegradable polyester that conforms ...Learn More
Dismissal of pain-pump lawsuit against 4 medtech firms upheld
A lower court's decision to dismiss a whistleblower lawsuit filed against Stryker, DJO Global, Orthofix and I-Flow has been ...Learn More
FDA OKs new device for preserving donated lungs
The FDA has approved the use of the XVIVO Perfusion System, a new device that preserves donated lungs for up to four hours ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
The mind is not a vessel to be filled but a fire to be kindled.
Plutarch, Greek ...Learn More
Retina's vision-correcting microchip lands German reimbursement
The German government has approved reimbursement coverage for Retina Implant's Alpha IMS technology, an implantable ...Learn More
Biosign agrees to $1.8M sale of medical device line
Biosign Technologies has agreed to divest itself of its Pulsewave line of medical devices and sell it to Global Life Safety ...Learn More
Smiths Medical's facility expansion could add 35 jobs in Conn.
Smiths Medical is spending $1 million to add 20,000 square feet of space to its existing facility in Southington, Conn., ...Learn More
ESensor detection tech boosts Q2 revenue for GenMark
GenMark Diagnostics generated revenue of $6.6 million during the second quarter, an increase from $5.2 million during the ...Learn More
EU approves Minimus Spine's ozone-delivery device
The TrioJection System, developed by Minimus Spine, has earned the CE mark in Europe. ...Learn More
Advanced Cell set to launch RNAscope products in Europe
Advanced Cell Diagnostics, which specializes in molecular diagnostics, has announced that its polymerase chain ...Learn More
Mount Sinai to bring Illumina's prenatal test to Ontario
Illumina has agreed to allow Mount Sinai Services to offer its Verifi test in Ontario for undisclosed terms. ...Learn More
Exact Sciences gains FDA approval for at-home colon cancer test
The FDA on Monday approved an at-home, DNA-based colorectal screening test from Exact Sciences that can spot genetic ...Learn More
A-fib patient in Utah sees wireless pacemaker as a lifesaver
Susan Thomas, a 72-year-old patient in Utah who was diagnosed with atrial fibrillation, has improved mobility after ...Learn More
Former senators tapped to lobby for Medtronic-Covidien merger
Medtronic has enlisted former Sens. John Breaux and Trent Lott to lobby for the company's pending merger with Covidien. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
I couldn't wait for success, so I went ahead without it.
Jonathan Winters, American ...Learn More
Medtronic gets FDA OK for 2 defibrillators, quadripolar lead
The FDA has granted Medtronic approval for its Viva Quad S and Viva Quad XT cardiac resynchronization therapy ...Learn More
LabStyle ramps up commercialization of blood glucose monitor, exec says
LabStyle Innovations is bolstering its effort to bring the Dario system, a smartphone-based device used to monitor blood ...Learn More
Cancer Dx tests boost Q2 revenue for Genomic Health
California-based Genomic Health posted $70.5 million in revenue during the second quarter, an increase from $63.7 million ...Learn More
CareFusion reports Q4 growth, plans $750M share repurchase program
CareFusion saw a 24% growth in sales and a 28% rise in profits during its fiscal fourth quarter. ...Learn More
New medtech rules in Germany include nonactive implant provisions
German regulators have adopted new medical device rules that include provisions governing nonactive implants. ...Learn More
Advanced pacemaker from Medtronic set to debut in India
The Viva cardiac resynchronization therapy-pacemaker, which earned the CE mark in Europe earlier this year, is being ...Learn More
Imaging provides new view of blood flow in the brain
Stanford University researchers have created a noninvasive high-resolution imaging technique that traces blood flow in the ...Learn More
2 mobile X-ray devices introduced by Meridian
Meridian Medical Systems has introduced the Paragon True-20 system, a mobile X-ray machine that comes with a lateral and ...Learn More
CMS delays launch of Sunshine Act reporting website
The CMS said Thursday that it will postpone the scheduled Sept. ...Learn More
Toshiba gains FDA clearance for vascular imaging tool
The FDA has cleared Toshiba America Medical Systems to market its Superb Micro-Vascular Imaging tool, which the company said ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
Do the best you can in every task, no matter how unimportant it may seem at the time. No one learns more about a problem than the person at the bottom.
Sandra Day O'Connor, former U.S. Supreme Court ...Learn More
St. Jude Medical wraps up $200M purchase of NeuroTherm
St. ...Learn More
IPO brings in $57M for T2 Biosystems
T2 Biosystems, which specializes in MRI-based infection diagnostic tools, has obtained $57 million in an initial public ...Learn More
Leica strikes companion Dx development deal with Bristol
Leica Biosystems, a unit of Danaher, has agreed to develop fully automated companion diagnostic tests that can be used to ...Learn More
NanoString wins reimbursement coverage for breast cancer assay
Testing services that use NanoString Technologies' Prosigna Breast Cancer Gene Signature Assay will receive reimbursement ...Learn More
Former Baxano exec named sales VP of SpineFrontier
John Miller has been named vice president of sales at SpineFrontier, which specializes in spinal surgery implants and ...Learn More
Hologic gains license for DEXA imaging tool in Canada
Health Canada has granted a medical license to Hologic's Horizon technology, a dual-energy X-ray absorptiometry imaging ...Learn More
Aethlon prepares to launch U.S. studies of infection device
Aethlon Medical is gearing up for the first FDA-approved U.S. ...Learn More
Pilot trials underway for novel skin cancer imaging device
U.S. ...Learn More
FDA ban on 510(k) split predicates draws mixed reaction
Some industry stakeholders lauded the FDA's decision to prohibit the use of split predicates under the 510(k) program, ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Patience often gets the credit that belongs to fatigue.
Franklin Jones, American ...Learn More
SynCardia wins FDA nod for key component of artificial heart
SynCardia Systems' SynHall valves, the last component necessary for the production of the company's Total Artificial Heart, ...Learn More
Large medtech firms saw steady job gains in 2013, report finds
Twelve of the 15 biggest medical device manufacturers saw steady employment growth last year, according to an EP Vantage ...Learn More
Prenatal microarray tests boost Q2 revenues for CombiMatrix
CombiMatrix generated $1.9 million in revenues during the second quarter, up from $1.5 million during the same period last ...Learn More
Rex Bionics names former Smith & Nephew exec as new CEO
Crispin Simon, the former president of Smith & Nephew's endoscopy unit, has been tapped to serve as CEO of Rex Bionics, ...Learn More
Growth forecast for global orthopedic soft-tissue repair market
The global orthopedic soft-tissue repair market is poised for growth, driven by the aging population and the prevalence of ...Learn More
Podcast: Medtech legends and leaders on the state of medical device innovation
On July 15, MassDevice.com brought together CEOs from BiOM, Haemonetics, Insulet, Kips Bay Medical and MC10 to discuss the ...Learn More
REBIScan's device shows promise in pediatric vision loss study
REBIScan's device that uses polarized light to detect vision loss in pediatric patients showed promising results in a ...Learn More
DFINE's tumor ablation device shows positive trial results
A study in the Pain Physician journal showed that patients who received radio frequency ablation using DFINE's STAR Tumor ...Learn More
New blood imaging and analysis tool detects malaria
A mobile health tool has been designed to provide quick analysis of blood samples for the diagnosis of diseases such as ...Learn More
FDA sets review date for SonaCare's prostate cancer device
A panel of FDA advisers will convene on Oct. ...Learn More
St. Jude, Abbott score reimbursement wins for heart devices
St. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
Failure is an event -- never a person.
William Brown, American ...Learn More
Hill-Rom's $250M purchase of Trumpf Medical finalized
Hill-Rom has wrapped up its purchase of German firm Trumpf Medical, along with its operating-room technologies, for $250 ...Learn More
Calif. molecular Dx firm obtains $12M in debt financing
SWK Funding has granted Response Genetics a credit facility worth as much as $12 million. ...Learn More
Bone suppression tool boosts revenue growth for Riverain
Revenues posted by Riverain Technologies in the first half of this year rose 34% compared with the same period last year. ...Learn More
DuoFertility to upgrade fertility monitor with $4M in fresh capital
A funding round has brought in $4.38 million for Cambridge Temperature Concepts, which has developed the DuoFertility system ...Learn More
New Zealand amends definitions for medical devices, drugs
Medsafe, New Zealand's drug and medtech regulator, has implemented its revised definitions for pharmaceutical and medical ...Learn More
CRO taps Ventana to provide companion Dx services in China
Ventana Medical Systems, a Roche unit, has struck a distribution deal with Quintiles, a contract research organization. ...Learn More
Study shows promising results for Bacterin's bone allograft
A study in the Journal of Foot & Ankle Surgery showed that trial participants saw substantial disability and pain ...Learn More
App to detect anemia nabs top prize at Microsoft tech challenge
A mobile health application that can be used to detect anemia in patients has nabbed the top prize at the 2014 Microsoft ...Learn More
2 patents issued to Baxano Surgical in U.S.
The number of U.S. ...Learn More
GE Healthcare seeks regulatory clearance for new PET/MR device
GE Healthcare is seeking FDA 510(k) clearance for its new Signa PET/MR scanner, which combines 3-Tesla MR technology with ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
You can't build a reputation on what you are going to do.
Henry Ford, American ...Learn More
Tecomet to pay $450M for Symmetry's orthopedic component unit
Tecomet has agreed to pay Symmetry Medical $450 million to acquire its OEM Solutions unit, which supplies instruments, ...Learn More
Eye surgery device firm closes $8M funding round
LensAR, which has developed an eye surgery device that uses lasers to treat presbyopia, has completed its $8 million ...Learn More
OHMK Medical buys 37.21% stake in EndyMed
OHMK Medical Technology has acquired a 37.21% stake in EndyMed, a maker of radio frequency-based medical devices, for $7 ...Learn More
Lubrizol expands health care footprint with Vesta buy
Lubrizol has strengthened its foothold in the health care space with its acquisition of Vesta Funding. ...Learn More
Medtronic launches hemodialysis facility in China
Medtronic has announced the launch of its facility in China that will house most of the firm's hemodialysis device ...Learn More
EU approves Transluminal Technologies' vascular closure system
European regulators have given Transluminal Technologies the CE mark for a device designed to seal arteriotomies in patients ...Learn More
Luminex's technology aids in Ebola Dx test development
Luminex reports that its xMAP technology is being used by the U.S. ...Learn More
DTRAX technology used in cervical spinal procedure in Wash.
A doctor at EvergreenHealth in Washington state has performed a procedure to stabilize the posterior cervical spine using ...Learn More
Carestream equips DR room with movement feature
Carestream Health has incorporated a Motor Assist capability into its DRX-Evolution digital radiography room. ...Learn More
ElMindA gains FDA clearance for brain analysis tool
The FDA has cleared ElMindA to market its device designed to assess brain activity in a noninvasive manner using signal ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Being defeated is often a temporary condition. Giving up is what makes it permanent.
Marilyn vos Savant, American ...Learn More
Cohera gains FDA panel support for surgical adhesive
A panel of FDA advisers has agreed to endorse approval for Cohera Medical's TissuGlu surgical adhesive, saying the ...Learn More
Catalent raises $871M from IPO; Lantheus delays IPO plans
Catalent, which develops drug delivery technologies, has obtained $871 million in an initial public offering. ...Learn More
Ohio surgical device firm advances funding round aiming for $10M
Ohio-based Checkpoint Surgical has secured nearly $7.5 million of a hoped-for $10 million financing round. ...Learn More
Stock offering planned by bone graft material company
Bacterin plans to sell common shares and apply part of the net proceeds to support general corporate functions. ...Learn More
Enforcement of new device, drug rules in Japan set for November
Regulators in Japan plan to implement its amended law governing medical devices and drugs marketed in that country on Nov. ...Learn More
Wyoming medical center buys electrolarynx devices for ICU
Wyoming's Cheyenne Regional Medical Center used grant money to purchase three electrolarynx devices for its ICU. ...Learn More
Sinus device with electromagnetic navigation unveiled by Medtronic
The NuVent EM Sinus Dilation System, which uses electromagnetic navigation to enable precise balloon placements, has been ...Learn More
EU trial begins for Implandata's wireless eye implant
Implandata Ophthalmic Products said it has initiated a clinical study in Europe to test the use of its Pro-IOP system in ...Learn More
FDA guidance would allow certain devices to skip 510(k) process
Draft guidance released by the FDA would allow certain devices to be released in the market without undergoing the 510(k) ...Learn More
Medicrea wins FDA nod for cervical fixation device
The FDA has granted Medicrea approval for its K-Jaws technology to be used for cervical fixation procedures involving ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
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
Censorship reflects a society's lack of confidence in itself.
Potter Stewart, U.S. Supreme Court ...Learn More
FDA plans to subject lab-developed tests to regulatory oversight
The FDA has issued a guidance document detailing the agency's plans to regulate tests developed by laboratories. ...Learn More
For more:
Read a statement from AdvaMed commending the FDA's issuance of a draft framework for laboratory-developed test ...Learn More
3D Systems to pay $120M for surgical simulation tech firm
3D Systems has agreed to pay $120 million to acquire Simbionix, which develops 3D virtual reality tools for surgical ...Learn More
Cura to enter ultrasound market with DE Healthcare buy
Cura Healthcare, an India-based medical device company, has struck a deal to acquire DE Healthcare, a diagnostic imaging ...Learn More
Japan OKs monitor/defibrillator combo from Zoll Medical
Japanese regulators have granted Zoll Medical the green light to market its R Series system, which combines an automated ...Learn More
2 brain monitors from Vittamed gain approval in Europe
Regulators in Europe have given Vittamed the CE mark for a pair of devices that use ultrasound technology to monitor the ...Learn More
Report: Worldwide surgical device market poised for growth
A report from Allied Market Research forecasts that by 2020, the worldwide market for surgical equipment could be worth ...Learn More
Rotation Medical announces first use of its rotator cuff in U.S.
Rotation Medical's Rotator Cuff System will be used for the first time in the U.S. ...Learn More
J&J unit unveils guiding catheters for neurovascular procedures
Two guiding catheters tailored for use during neurovascular surgery are being launched by Codman Neuro, a unit of Johnson & ...Learn More
FDA's OK for Abiomed heart pump may come 2 months sooner
Abiomed said the FDA could reach a decision on its premarket approval application for the Impella device by March, two ...Learn More
Mauna Kea's advanced endomicroscopy technology gets FDA OK
The FDA has cleared Mauna Kea Technologies to market an advanced version of its Cellvizio endomicroscopy device. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
No one wants advice -- only corroboration.
John Steinbeck, American ...Learn More
FDA proposes device user fee reductions for FY 2015
The FDA's device center has issued a proposal to lower the medical device user fees for fiscal year 2015 by 3% across the ...Learn More
Report: X-ray market in U.S. could be worth $1.1B in 6 years
A GlobalData report forecasts that the U.S. ...Learn More
Blood pressure assets of Centron purchased by SunTech Medical
Blood pressure management firm SunTech Medical has agreed to pay an undisclosed sum to acquire the assets of Centron ...Learn More
Epic Sciences to advance cancer test with $30M in fresh capital
Epic Sciences has obtained $30 million in Series C financing, which CEO Murali Prahalad said will be used to bring the ...Learn More
EU adopts hazardous material restrictions for medical devices
The European Commission has adopted new rules mandating that all medical devices, except active implants, satisfy the ...Learn More
Report forecasts growth for global trauma fixation device market
A Transparency Market Research report predicts that the worldwide market for orthopedic trauma fixation systems could be ...Learn More
Calhoun Vision tackles the "Holy Grail" of ophthalmology with new lens
For years, the "Holy Grail" of ophthalmology has been to give patients the ability to see clearly in both near and far ...Learn More
Invitae enters genetic cancer test partnership with Nanopharmacia
Invitae will make its genetic assays for hereditary cancers available in Mexico under a deal reached with Nanopharmacia. ...Learn More
Glide Pharma gains rights to FScan's prostate cancer Dx technology
Glide Pharmaceutical Technologies was granted exclusive licensing rights to a prostate cancer diagnostic technology ...Learn More
Technology allows accurate detection of secondary cataracts
Spanish researchers have created a fully automatic tool that they say can detect posterior capsule opacity, or secondary ...Learn More
Proposed Mass. tax credit would offset 2.3% device tax
The fiscal 2015 budget approved by Massachusetts Gov. ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Against the assault of laughter nothing can stand.
Mark Twain, American ...Learn More
Final rule prohibits "split predicates" under 510(k) process
The FDA has released a final rule disallowing use of "split predicates" under the agency's 510(k) clearance program. ...Learn More
Investors pump $172M into smart pill tech developer
Proteus Digital Health, which has developed a smart pill system with embedded sensors that link to a skin patch, has secured ...Learn More
Maker of smartphone-based vision testing device obtains $4M
A Series A funding round has pulled in $4 million for EyeNetra, the maker of a smartphone-based device that can be used to ...Learn More
Sequenom signs licensing deal with Mayo, posts Q2 revenue growth
Sequenom has agreed to license patents and applications related to its noninvasive prenatal tests to Mayo Medical ...Learn More
Medtronic strikes pacemaker manufacturing deal in China
Lifetech Scientific will work with Medtronic to manufacture pacemakers under an expanded deal reached between the companies. ...Learn More
AstraZeneca signs companion diagnostic deals with Roche, Qiagen
AstraZeneca has tapped Roche Holding and Qiagen to develop separate blood-based tests that can be used as companion ...Learn More
New device uses microscopic laser beams to draw blood
Scientists at NoNeedles Venipuncture are developing a new process that uses laser pulses instead of a needle to draw blood. ...Learn More
Intellijoint gains FDA OK for smart tool used during hip surgery
The FDA has cleared Intellijoint Surgical to market a smart tool designed to aid surgeons when performing hip replacement ...Learn More
Gonorrhea, chlamydia tests from Becton Dickinson win FDA nod
BD Diagnostics has received FDA clearance for a pair of tests used to detect gonococcal urogenital disease and chlamydia in ...Learn More
FDA OK for lung infection device sought by Asthma & Allergy
Asthma & Allergy Prevention Co. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
To invent, you need a good imagination and a pile of junk.
Thomas Edison, American ...Learn More
Medtech firms paid $1.4B in excise taxes in 2013, IRS data show
Data from the Internal Revenue Service indicate that medtech firms made excise tax payments of $1.4 billion last year when ...Learn More
Medtronic to pay up to $105M for laser ablation device firm
Medtronic has agreed to acquire Visualase, the maker of an MRI-guided laser ablation system used during minimally invasive ...Learn More
T2 Biosystems amends IPO target to as much as $65.9M
An initial public offering earlier announced by T2 Biosystems could bring in as much as $65.9 million in net proceeds, ...Learn More
Augmenix hopes to advance surgical hydrogel with $10.8M in financing
Augmenix has raised $10.8 million in Series D financing, which the Massachusetts-based company aims to use to support its ...Learn More
HealthTrust signs molecular Dx supply deal with BioFire
HealthTrust has tapped BioFire Diagnostics to supply its provider network with the company's multitarget molecular ...Learn More
Outgoing CFO of Covidien named to Haemonetics board
Charles Dockendorff has been appointed to serve on the board of directors at Haemonetics. ...Learn More
New GMP rules for medical devices proposed in S. Korea
The Ministry of Food and Drug Safety in South Korea has issued a proposal amending its good manufacturing practice rules for ...Learn More
Mainstay gets green light to expand ReActiv8 trial in U.K.
U.K. regulators have given Mainstay Medical the go-ahead to add U.K. ...Learn More
Advanced cervical-disk implant from Medtronic wins FDA nod
Medtronic has won FDA approval to market an updated version of its Prestige cervical-disk implant launched in 2007. ...Learn More
Quidel's Group A strep test lands FDA clearance
Quidel has received clearance from the FDA to market its AmpliVue GAS Assay. ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
We must open the doors of opportunity. But we must also equip our people to walk through those doors.
Lyndon B. Johnson, 36th U.S. ...Learn More
Sorin's next-gen heart valve wins approval in Europe
Sorin has earned the CE mark in Europe for its Crown PRT, a next-generation device used to treat patients with aortic valve ...Learn More
Cardiovascular molecular Dx firm advances $25M funding round
A regulatory filing disclosed that CardioDx has obtained $21 million in a funding round aiming for $25 million. ...Learn More
Funding round brings in $6M for CyMedica Orthopedics
CyMedica Orthopedics has pulled in $6 million in a financing round, according to a regulatory filing. ...Learn More
Minn. surgical-waste-management firm obtains funds
Skyline Medical, which specializes in surgical-waste management, has received from two undisclosed backers more than ...Learn More
Surgical-implant business helps boost Q2 sales for DJO Global
DJO Global posted $313.9 million in net sales during the second quarter, a 6.5% increase over the same period in 2013. ...Learn More
Canadian hospital gets $1.4M boost to build molecular oncology lab
The Ottawa Hospital is set to establish a molecular oncology diagnostic facility using $1.4 million in financing. ...Learn More
Ohio hospital first to use Aurora's bone allograft in U.S.
A doctor at Madison County Hospital in Ohio has performed the first U.S. ...Learn More
Qiagen gains license for potential blood cancer biomarkers
Qiagen has licensed four biomarkers from the University of Tokyo that can be used for assessing treatment prognosis in blood ...Learn More
MIT-developed test offers cheaper, easier way to detect cancer
A professor at the Massachusetts Institute of Technology has created an assay that can be used to detect cancer with the ...Learn More
Medtronic agrees to pay $2.8M to settle insulin pump lawsuit
Medtronic has reached a $2.8 million settlement deal with the federal government and 36 states to resolve a lawsuit accusing ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
There is no disguise which can hide love for long where it exists, or simulate it where it does not.
Francois de La Rochefoucauld, French ...Learn More
Boston Scientific's drug-coated balloon wins EU approval
Regulators in Europe have granted the CE mark to Boston Scientific's Agent balloon catheter, designed to treat patients with ...Learn More
Pa. cardiovascular device firm lands $3.85M investment
Pennsylvania-based Intelomed, the maker of a noninvasive tool for real-time detection of a patient's risk for cardiovascular ...Learn More
3 medtech startups receive $100K each in Md. innovation awards
Three startups developing medical technologies won investments worth $100,000 each from the Maryland Innovation Initiative. ...Learn More
Illumigene products help fuel FY Q3 sales growth for Meridian
Meridian Bioscience generated $47.2 million in sales during the company's fiscal year 2014 third quarter, up from $47.1 ...Learn More
Millstone Medical to expand facility, workforce in Mass.
Millstone Medical Outsourcing has announced plans to add 40,000 square feet to its existing medical-device packaging and ...Learn More
Elekta hopes to expand footprint in Turkey with Mesi Medikal buy
Elekta has agreed to acquire Mesi Medikal, a distributor of radiation therapy devices in Turkey, for undisclosed terms. ...Learn More
Grifols gets CE mark for hepatitis E detection test
Grifols has earned the CE mark in Europe for the Procleix HEV test, which it developed with Hologic. ...Learn More
Study of staph infections on implanted devices wins $10M grant
A University of Nebraska Medical Center study of antibiotic-resistant infections related to implanted devices has won a $10 ...Learn More
Philips' mobile ultrasound scanner scores FDA clearance
The FDA has cleared Philips Healthcare to market its Visiq system, a mobile ultrasound scanner designed to ease the way ...Learn More
FDA OKs Spectranetics' devices to treat in-stent restenosis
Spectranetics has received 510(k) clearance from the FDA for its Turbo Elite and Turbo-Tandem peripheral atherectomy ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
The important thing in life is not to have a good hand but to play it well.
Louis Fortin, ...Learn More
Teleflex's chronic hemodialysis catheter wins FDA nod
The FDA has cleared Teleflex to market its Arrow-Clark VectorFlow catheter, designed for use in patients undergoing chronic ...Learn More
Infectious-disease-product sales boost Q2 revenue for Quidel
Quidel posted $31.5 million in revenue during the second quarter, up from $29.7 million during the same period last year. ...Learn More
Connecticut Innovations awards $10K each to 2 medtech startups
Vesselon and 109 Design were among five startups in Connecticut that won $10,000 each through Connecticut Innovations' ...Learn More
ConMed picks former Stryker exec to serve as interim CEO
Former Stryker Chief Financial Officer and interim CEO Curt Hartman has been tapped to serve as interim CEO of ConMed. ...Learn More
New medtech classification system proposed in Russia
Regulators in Russia have proposed a new system to classify medical devices in that country based on the Global Medical ...Learn More
IMRIS' surgical theater with advanced MRI feature gains CE mark
IMRIS has won CE mark approval in Europe to market its Visius Surgical Theatre, which features a next-generation version of ...Learn More
Podcast: CEO Brian Concannon on the past and future for Haemonetics
Haemonetics CEO Brian Concannon discusses how the company will transform blood management in the coming years at ...Learn More
NeuroPace partners with DARPA on memory-loss study
The Defense Advanced Research Projects Agency has tapped NeuroPace to investigate the use of implantable neurostimulators to ...Learn More
Lung cancer study to use Foundation Medicine's assay
The Bonnie J. ...Learn More
Breast density software from VuCOMP cleared in Canada
VuCOMP has received the green light to market its M-Vu Breast Density technology in Canada. ...Learn More
Proposed Sunshine regulations could mean new costs for medtech firms
Experts have voiced concerns that proposed changes to the Physician Payments Sunshine Act, which requires health care firms ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Progress begins with the belief that what is necessary is possible.
Norman Cousins, American ...Learn More
St. Jude earns CE mark for next-gen heart ablation device
St. ...Learn More
J&J's $5B share repurchase program wins board approval
A plan by Johnson & Johnson to buy back as much as $5 billion of its stock has been approved by the company's board. ...Learn More
First tranche of Trice Medical's $11.6M funding round completed
Trice Medical has completed the first part of its Series B funding round aiming for $11.6 million. ...Learn More
Mass. miRNA assay firm advances $1.5M funding round
A funding round aiming for $1.5 million has brought in $775,000 for Firefly BioWorks. ...Learn More
Hanson tapped to serve as group president at Covidien
Bryan Hanson, president of Covidien's medical device unit, has been appointed to serve as the company's group president. ...Learn More
Comments sought on EU proposal to evaluate nano-based devices
The European Commission has released preliminary guidelines governing the risk assessment of medical devices that use ...Learn More
Company developing point-of-care Dx test gets $2.5M boost
SenGenix, a Duke University spinoff, has received $2.5 million from investors. ...Learn More
N.Y. grants final approval for Rosetta's kidney cancer test
The Department of Health in New York state has given Rosetta Genomics final approval to offer its kidney cancer test in the ...Learn More
Advanced intravascular ultrasound introduced by Boston Scientific
Boston Scientific has expanded its intravascular ultrasound product line with the release of its Polaris system. ...Learn More
FDA gives green light to Veniti's venous stent trial
The FDA has granted Veniti investigational device exemption to conduct a clinical study of its Vici Venous Stent System, ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
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
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
When it comes to human dignity, we cannot make compromises.
Angela Merkel, German ...Learn More
FDA OKs NeuroMetrix's chronic pain device for nonprescription use
The FDA has cleared NeuroMetrix to market a wearable device designed to treat chronic pain without the need for a ...Learn More
Airway mapping device firm advances $7.5M funding round
A group of 18 undisclosed backers has pumped $6.5 million into Veran Medical Technologies, bringing the company closer to ...Learn More
Mariel buys Stryker's bone morphogenetic protein-7 assets
Mariel Therapeutics has agreed to acquire the bone morphogenetic protein-7 assets of Stryker for undisclosed terms. ...Learn More
Biomatrica licenses reagent technology to Microbiologics
Biomatrica has granted Microbiologics licensing rights for its RNAstable and DNAstable reagents used to stabilize RNA and ...Learn More
Former Acclarent exec named COO of Benvenue Medical
Jeffrey Jones has been tapped to serve as chief operating officer of Benvenue Medical. ...Learn More
Magnetodyn to sell patented bone, tissue regeneration tech
Magnetodyn has struck a deal to sell patents related to its bone and tissue regeneration technology to German firm Munich ...Learn More
Swiss bioinformatics firm obtains $13.75M in Series B financing
A Series B round of financing has pulled in $13.75 million for Sophia Genetics. ...Learn More
Startup behind pill-scanning device gets funding boost
Mint Solutions has raised $6 million in a round of Series A financing headed by Seventure Partners and Life Sciences ...Learn More
Nortis eyes 2015 release of organ-mimicking microfluidic chip
Nortis has obtained $2 million in financing, which CEO Thomas Neumann said will be used to help bring the company's ...Learn More
Uterine fibroid devices to undergo FDA scrutiny
An FDA panel of advisers will convene on Thursday and Friday to explore possible changes to the labeling, instructions for ...Learn More
Premarket Approval (PMA) Submissions Workshop
Thursday, Oct. 23 – Friday, Oct. ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
Failure is simply the opportunity to begin again, this time more intelligently.
Henry Ford, American ...Learn More
FDA lowers regulatory bar for headache devices
The FDA has lowered the risk classification of noninvasive systems to treat headache from Class III to Class II devices with ...Learn More
N.J. maker of insulin delivery device obtains about $22M
Valeritas has secured approximately $22 million in a funding round that the company hopes will bring in up to $45 million. ...Learn More
Natera enters genetic-test partnership with Mount Sinai
The Mount Sinai Genetic Testing Laboratory has agreed to provide Natera's Horizon test used for genetic-carrier screening. ...Learn More
Former AtriCure CEO takes the helm of JenaValve
David Drachman has been appointed to serve as the new CEO of JenaValve, the maker of a transcatheter aortic valve implant ...Learn More
ArcticDx signs deal to bring its AMD test to Canada
ArcticDx has granted AMD Insight exclusive licensing rights for its Macula Risk PGx assay, designed to assess a patient's ...Learn More
Firms ally to develop tests to customize statin drugs
A deal struck between Genomas and AutoGenomics aims to create genetic assays and DNA-based diagnostic tools that can be used ...Learn More
Advanced X-ray angiography system unveiled by Toshiba
An advanced X-ray angiography device, called Infinix Essential, has been introduced by Toshiba America Medical Systems. ...Learn More
Diazyme's iron deficiency test lands FDA clearance
The FDA has cleared Diazyme Laboratories, a General Atomics unit, to market its ferritin immunoturbidimetric assay for ...Learn More
CAS Medical reaches settlement deal with Covidien unit
CAS Medical said it has agreed to pay Covidien unit Nellcor $275,000 to settle a patent litigation with prejudice. ...Learn More
FDA input sought by Mainstay Medical for ReActiv8 system
A pre-investigational device exemption information package has been presented to the FDA by Mainstay Medical for the ...Learn More
Investigational Device Exemption (IDE) Submission Workshop
Wednesday, Oct. ...Learn More
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
Let no one ever come to you without leaving better and happier.
Mother Teresa, Albanian-Indian nun and ...Learn More
Thoratec to acquire Apica Cardiovascular for up to $75M
Thoratec has agreed to acquire Apica Cardiovascular for $35 million in cash, plus as much as $40 million in milestone fees. ...Learn More
Shares offering could pull in $6.8M for GeneNews
Toronto-based GeneNews, which specializes in molecular diagnostic tests, seeks to obtain $6.8 million in a private shares ...Learn More
Veracyte's genomic test scores reimbursement win from 2 insurers
Veracyte's Afirma Gene Expression Classifier has been found by Horizon Blue Cross Blue Shield of New Jersey and Highmark to ...Learn More
Echo Therapeutics names interim CEO, looks for new CFO
Kimberly Burke has been tapped to serve as interim CEO of Echo Therapeutics until Aug. 30 or when a permanent CEO is hired. ...Learn More
NuVasive to build global operations center in Ireland
California-based NuVasive, which specializes in minimally invasive spinal surgery devices, is setting up an international ...Learn More
Strong growth forecast for Chinese X-ray imaging market
GlobalData predicts the Chinese market for X-ray imaging systems could be worth $1 billion by 2020, driven in part by the ...Learn More
Medtronic's device fares better than daily injections in diabetes trial
A clinical study of more than 330 participants in Canada found that type 2 diabetes patients using Medtronic's MiniMed ...Learn More
Vital-signs-monitoring chair from EarlySense gains FDA OK
The FDA has cleared EarlySense to market a sensor that can monitor a patient's heart rate, respiratory rate, movement and ...Learn More
510(k) Submissions Workshop
Monday, Oct. 20 – Tuesday, Oct. ...Learn More
Join the AdvaMed-MTLI LinkedIn group!
Build close relationships with member companies, both small and large, and receive an intimate understanding of the key ...Learn More
The important thing is not to stop questioning.
Albert Einstein, German-American theoretical ...Learn More
T2 Biosystems plans to go public to raise $69M
T2 Biosystems, which develops MRI-based infection diagnostic tools, hopes to raise up to $69 million in an initial public ...Learn More
Abiomed pays more than $30M for 2 German medtech firms
Abiomed has agreed to acquire Entwicklungsgessellschaft, a German firm developing a catheter-based heart pump, for $13 ...Learn More
Rotation Medical obtains $27.2M in Series B financing
A Series B funding round has brought in $27.2 million for Rotation Medical, the maker of a collagen scaffold designed to ...Learn More
Report: Worldwide companion Dx market poised for robust growth
A Research and Markets report forecasts that the worldwide companion diagnostics market, which reached $26 billion last ...Learn More
Podcast: Covidien's Enxing Seng talks Medtronic merger, future of medicine at DeviceTalks
Covidien's Stacy Enxing Seng speaks to MassDevice.com about the Medtronic merger during our DeviceTalks Minnesota ...Learn More
Research project aims to evaluate immune competence
The Singapore Immunology Network will work with French molecular diagnostics company ImmunID on a clinical study evaluating ...Learn More
Thermedx's fluid-warming technology wins expanded FDA OK
The FDA has given Thermedx expanded clearance to market its fluid-warming system for use during hysteroscopic and ...Learn More
FDA's 4-year plan includes focus on safety and quality
The FDA has issued a draft document outlining a four-year plan that will focus on five key areas, including regulatory ...Learn More
St. Jude resolves manufacturing issues at Calif. plant
The FDA has issued a notice clearing St. ...Learn More
Helping medical technology professionals keep pace with regulatory and compliance issues
AdvaMed-MTLI and UL EduNeering have recently launched the AdvaMed Regulatory and Compliance Certificate (ARCC) Program for ...Learn More
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
SmartBrief will not publish Friday
In observance of Independence Day in the U.S., SmartBrief will not publish on Friday. Publication will resume ...Learn More
Beware; for I am fearless, and therefore powerful.
Mary Shelley, English ...Learn More
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
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
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
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
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
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
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
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 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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
See AdvaMed-MTLI's schedule of courses
Don't miss your turn to learn! See AdvaMed-MTLI's schedule of courses ...Learn More
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
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
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
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
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
See AdvaMed-MTLI's schedule of courses
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
See AdvaMed-MTLI's schedule of courses
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
See AdvaMed-MTLI's schedule of courses
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
Follow AdvaMed on Google+
Stay updated on industry news and educational opportunities -- receive an intimate understanding of the key issues affecting ...Learn More
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
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 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


sign up
for a daily briefing on top stories in the medical technology and diagnostics industries, FREE
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.

Learn More
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. 

Learn More
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.

 
Learn More
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.  

Learn More


Twitter FeedTwitter
Twitter
@ AdvaMedUpdate