An FDA advisory panel votes that French device maker Edap failed to demonstrate that its novel Ablatherm prostate cancer treatment is safe and effective.
A voluntary recall initiated yesterday pushes HeartWare shares down today, despite 2nd-quarter result that crushed expectations on Wall Street.
HeartWare International (NSDQ:HTWR) shares took a hit today after the medical device company revealed a voluntary recall for its implantable heart pump.
Lantheus Medical Imaging spikes plans for a $125 million initial public offering, citing 'poor market conditions.'
Lantheus Medical Imaging reportedly spiked an initial public offering it hoped would raise $125 million, citing "poor market conditions," Renaissance Capital reported.
Boston-based Vittamed wins CE Mark approval for devices to monitor intracranial pressure and cerebral perfusion.
Medtech maker Vittamed won CE Mark approval for a pair of ultrasound-based systems for monitoring intracranial pressure and cerebral perfusion, the company announced.
European regulators approved Vittamed's 205 intracranial pressure measurement and the 505 cerebrovascular autoregulation monitor, both of which use non-invasive headsets to monitor activity in the brain.
Abiomed said today that it expects the FDA to grant the pre-market approval application for its flagship Impella heart pump sooner rather than later, pushing up the timeline to March 2015.
Cleveland Clinic CEO Toby Cosgrove says hospital systems around the U.S. are looking for ways to reduce their costs by 15-20% over the next 5 years.
MASSDEVICE ON CALL — Hospital systems are looking to make major cuts to their spending as Medicare dollars become more scarce, and that means shrinking budgets for purchasing medical devices and other products.
Zoll Medical lands Shonin approval in Japan for its Series R combination monitor and automated external defibrillator.
Zoll Medical said today that it won Shonin approval from the Japanese Ministry of Health, Labor & Welfare for its R Series combination monitor and automated external defibrillator.
Counter-claims by an ex-Stryker sales rep can stand in a poaching dispute involving Biomet, a federal judge rules.
New materials regulations in the European Union mean medical devices have one more layer of red tape to cut through before they can reach the market.
Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.
The European Commission's new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.
NuVasive shares surge more than 10% as the medical device company raises its outlook for the rest of the year after posting 2nd-quarter sales and earnings numbers that beat estimates.
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The FDA is cutting the fiscal 2015 user fees paid by medical device companies to have their products reviewed by 3% across the board.
The FDA is cutting the user fees paid by medical device companies for the watchdog agency's review by some 3% across the board for fiscal 2015.
The FDA's Center for Devices & Radiological Health said today that it proposes to cut the fees for both small businesses making less that $100 million annually and for their larger brethren.
Massachusetts Gov. Deval Patrick establishes a commission to study a possible tax credit to offset the 2.3% excise tax on U.S. medical device sales for the Bay State's medtech cluster.
Massachusetts Gov. Deval Patrick is establishing a special commission to study granting a tax credit to the Bay State's medical device companies to offset the medical device tax.
Edwards Lifesciences chairman & CEO Michael Mussallem warns Congress that healthcare regulators and payers are cultivating an "alarming and documented decline in U.S. medical innovation."
Boston Scientific reportedly prevails in the 1st personal injury lawsuit to go to trial over its Pinnacle pelvic mesh product.
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
The FDA has been busy so far in 2014, with a raft of new guidances and proposals with important implications for companies developing new medical devices and digital health products.
MASSDEVICE ON CALL — The FDA released a spate of new guidances in the 1st half of 2014, several with important implications for medical device and digital health companies.
Law360.com picked out some of the highlights from the year, including measures that affect how healthcare companies can communicate over social media and new rules that relax oversight of healthcare data systems and clinical decision software.
Proteus Digital Health, which is backed by Medtronic, Novartis and others, raises more than $172 million in a Series G funding round in support of its sensor-embedded ingestible pills.
California-based Proteus Digital Health closed a Series G funding round this week with more than $172 million pledged in support of the company's ingestible sensor-laden pills.
FDA medtech regulators approve Medtronic's Prestige LP screw-free cervical disc for treatment of single-level cervical disc disease.
A recent spate of mega-mergers hasn't inspired medtech peers to follow suit just yet, according to leadership at Boston Scientific, C.R. Bard and Smith & Nephew.
The medical device industry has some blockbuster merger activity in recent months, but a few companies are sitting this one out.
Medical device regulators clamp down on the 510(k) review pathway, prohibited manufacturers from splitting their primary substantial equivalence claims between multiple devices.
Federal medical device regulators finalized a new rule this week that prohibits manufacturers from using so-called "split predicates" to establish that their new products are effectively the same as devices already on the market.
Healthcare-provider alliance SharedClarity signs some of medtech's biggest firms to land specialized pricing for peripheral stents.
Four of medtech's biggest firms agreed to offer peripheral stents at specialized prices to members of SharedClarity, an organization formed through the alliance of some of the country's largest health insurance and care providers.
Here's a look at some of the top regulatory stories for medical device companies this week: Medicare's Sunshine Act changes could hit device makers in the pocketbook; Indian regulators clarify requirements for medical device registrations, clinical trials; US FDA publishes insight into 510(k) Substantial Equivalence determination process; Russian regulators preparing new medical device classification system?; FDA dings Spinal Elements for design changes, unreviewed claims
Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine.
OCTANe and the Southern California Center of Technology & Innovation in Pediatrics join forces to spur innovation in pediatric medical devices and get more products to market.
MASSDEVICE ON CALL — Orange County, Calif., technology-backer OCTANe is teaming up with the Southern California Center of Technology & Innovation in Pediatrics (CTIP) to advance medical devices for chidren's health.
OCTANe plans to set up shop at the Children's Hospital of Las Angeles (CHLA), which operates the CTIP, to help commercialize new pediatric device with its "LaunchPad process of predictive analytics-based acceleration."
The IRS calculates that medtech companies paid the federal government $1.4 billion in medical device excise taxes in 2013, according to a response to a Freedom of Information Act request by MassDevice.com.
Medical device companies ponied up $1.4 billion in excise tax payments to the federal government in 2013 to pay for Obamacare, according to documents supplied to MassDevice.com by the Internal Revenue Service.
Varian passes on an acquisition option as Augmenix closes a Series D funding round with $10.8 million raised in support of its Space OAR hydrogel for protecting the rectum during prostate radiation therapy.
Massachusetts-based Augmenix is hoping it can make it to the U.S. market with the $10.8 million funding round it just closed, the company said this month.
After 2 failed attempts at FDA approval, Guided Therapeutics returns with an amended application for its LuViva cervical scanner.
Here's a look at some of the top legal news stories for medical device companies this week: Judge nixes alleged settlement in Stryker, Biomet poaching spat; Boston Scientific loses bids to exclude testimony in pelvic mesh trials; Occlutech claims another win over St. Jude Medical; Align Tech declares a 'total win' as federal circuit reverses ITC ruling; Report: Medtronic shareholder sues to block Covidien merger
The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.
By Stewart Eisenhart, Emergo Group
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
Charles Dockendorff, the outgoing CFO at Covidien, is named to the board of directors at Haemonetics.
Google's clandestine "X" labs looks to collect and analyze human genomic and molecular data in search of patterns and irregularities that may point to disease.
MASSDEVICE ON CALL — Technology titan Google (NSDQ:GOOG) is taking new interest in human health in the latest "moonshot" project coming out of its ambitious "X" lab, famous for self-driving cars and Google Glass.
Medtronic and Lifetech Scientific expand their deal to co-produce pacemakers for the Chinese market.
Skyline Medical reveals in an SEC filing that it raised about $733,000 to help pay its officers and directors.
Minnesota device maker issued a series of updates this month on its legal and financial dealings, including that it secured more than $733,000 to help pay for its corporate expenses.
Executives at C.R. Bard say the company is on track for an early 2015 approval for its Lutonix drug-eluting balloon for treating peripheral artery disease.
C.R. Bard (NYSE:BCR) is on track for an early 2015 U.S. approval of its Lutonix drug-eluting balloon, company executives said yesterday after reporting earnings growth that topped expectations.
Here's a look at some of the top funding stories for medical device companies this week: DICOM Grid raises $6M for cloud-based medical imaging systems; Welch Allyn leads $7M round for Cardiac Insight; Biolase launches $12M private placement amid internal turmoil, shares soar; Trice Medical reels in $12M, ex-Embrella founder O'Donnell
Covidien's fiscal 3rd-quarter sales come in dead even with expectations on Wall Street as its earnings top analysts' consensus estimate.
FDA's official blog brought to you from FDA's senior leadership and staff stationed at home and abroad - sharing news, background, announcements and other information about the work done at the FDA on behalf of the American public.
By: John Swann, Ph.D.
Elekta hopes to meet Turkey's radiotherapy "shortage" through its acquisition of local distributor Mesi Medikal.
Innovative technology adds to company's leading portfolio of treatment options for coronary artery disease.
Robot-assisted surgical devices maker Intuitive Surgical takes offense as doctors at a major U.S. cancer center warn that robot-assisted surgery may have little to offer patients undergoing surgical bladder removal.
The much-disputed field of robot-assisted surgery took another blow this week when doctors from Memorial Sloan Kettering Cancer Center warned that the high-tech procedure may be no better than traditional surgery for patients with invasive bladder cancer.
A Medtronic shareholder is reportedly looking to block the pending, $43 billion merger with Covidien, arguing that the deal leaves stockowners on the hook for significant tax liabilities.
Intersect ENT prices its initial public offering at $11 per share, the low end of its predicted range, hoping to raise $55 million when XENT shares hit the NASDAQ exchange today.
Intersect ENT said today that it's shares should hit the NASDAQ exchange at $11 apiece, the low end of the range, for expected proceeds of $55 million.
At that price, Intersect would command a market capitalization of roughly $267 million.
Here's a look at some of the top Wall Street stories for medical device companies this week: Abbott CEO defends inversions amid corporate exodus furor; Medtronic fights tax dodging rhetoric in Covidien merger; Allergan cuts 1,500 jobs, faces SEC complaint; A countdown to failure for Valeant's hostile $53B Allergan takeover; GE Healthcare idles for another quarter
Boston Scientific beats Wall Street's expectations and its own forecasts for 2nd-quarter sales and earnings, with strong performances from its core implantable cardiac defibrillator and drug-eluting stent businesses.
Medtech titan Medtronic has developed 175 iOS apps for internal use by its employees, according to Apple.
Trice Medical says it reeled in the 1st tranche of a nearly $12 million Series B round and named ex-Embrella Cardiovascular Jeffrey O'Donnell Sr. as chairman & CEO.
Trice Medical said it raised the 1st tranche of an $11.6 million Series B round and named medtech veteran Jeffrey O'Donnell Sr. as its new CEO.
The FDA wants CareFusion to stop selling its anesthesia breathing circuit and the Denver ascites shunt and percutaneous access kit until it applies for clearance for changes made to the devices and clears up some quality control issues at a plant in Illinois.
