News

FDA warns of potentially fatal problems with Covidien, Dräger ventilators

The FDA warned of a Covidien ventilator that may not deliver enough air, and another one from Dräger Medical that has faulty batteries. The ongoing corrective actions of about 2,700 units of the devices have been deemed Class 1, a designation reserved for situations "in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

'Heart in a box' reanimates hearts after death, increasing supply of donated organs

Transmedics' "heart in a box" has been used to preserve at least 15 hearts taken from dead patients in the the U.K. and Australia. The device increases the supply of donated hearts, which stands at about 2,400 per year in the U.S., where the technology is awaiting FDA approval.

Wright Medical gains on FDA approval of Augment Bone Graft

Orthopedic specialist Wright Medical is up almost 10% to a $1.2 billion valuation in early trading on the news that its Augment Bone Graft has been granted a PMA approval. It's slated for use as an alternative to auto-graft for ankle or hind-foot fusion indications.

EarlySense moves patient monitoring tech to at-home setting

Patient monitoring company EarlySense has been on a winning streak this past year, raking in new funds and striking deals with key industry players to build out its offerings. In the company's latest move, EarlySense is bringing its technology to home settings, rolling out a product geared toward sleep and wellness monitoring.

FDA partners with nonprofit device incubator Fogarty Institute to improve approval efficiency

The U.S. Food and Drug Administration and the Fogarty Institute for Innovation, one of the more prominent medical device incubators, have developed a new educational program designed to improve collaboration between medical device innovators and the FDA that's expected to make the device approval process more efficient.

HeartWare looks to diversify into mitral valve repair with $929M purchase of Valtech Cardio

HeartWare agreed to purchase Israel's Valtech Cardio for about $929 million, including milestone payments, in a stock-based transaction. It's common for patients receiving an LVAD to concurrently receive a mitral or tricuspid valve procedure, explaining why HeartWare boldly stepped out of its sole area of focus to acquire the relatively diversified Israeli company, transforming it from a specialist to a cardiology generalist.

On a recall, 3-D printed knee implant maker ConforMIS falls 25% to IPO price

ConforMIS had one of the most staggeringly successful med tech IPOs this summer. Its July IPO raised more than $155 million at a $15 share price. The custom 3-D printed orthopedic implant company saw its share price climb as high as almost $27--but all that ground has been lost on this week's news of a voluntary recall by the company.

FDA's regulatory decisions can be a headscratcher, as evidenced by these implants to fight stroke

Boston Scientific's stroke-fighting left atrial appendage closure device, the Watchman, suffered from an FDA rejection and other regulatory delays. It was approved this year, 10 years after achieving the milestone in Europe.

Next-gen infusion pump startup Ivenix nabs $42M to get to market

Infusion pumps are one of the more problematic categories of medical devices with myriad adverse events, including deaths, and recalls associated with the devices. Ivenix expects that its next-gen infusion management system could improve patient safety and workflow efficiency--as well as to adhere to more stringent FDA guidance on infusion systems issued in December.

Abbott bioresorbable stent comparable to its drug-eluting stent in Japanese trial

Abbott announced that its bioresorbable scaffold performed similarly to its traditional drug-eluting stent in a clinical trial for Japanese approval. The device is the market leader by far, and is already available in more than 90 countries, though not the U.S.

DynoSense selects Chinese marketing partner for hand-held monitoring device

Digital health startup DynoSense is teaming up with a Chinese health services company to bring its patient monitoring technology to China, expanding its global reach weeks after the company reeled in new funds to fuel stateside approval for its device.

NovoCure files for up to $300M IPO on strength of first-line glioblastoma device

NovoCure has filed for an IPO to raise up to $300 million on the strength of a potential FDA approval for its Optune device in combination with chemotherapy for patients with newly diagnosed glioblastoma.

CeQur reels in $100M for insulin infusion smart patch device

Swiss diabetes device maker CeQur roped in $100 million in a Series C round for its patchlike insulin infusion device, helping the company ramp up operations and launch its product next year.

Medtronic to buy cerebral aneurysm stealth startup Medina for $150M+

In its eighth disclosed acquisition this year, Medtronic will purchase vascular aneurysm player Medina Medical for $150 million plus additional undisclosed milestone payments. The stealthy startup already has a CE mark for its embolization device to treat cerebral aneurysm.

UPDATED: Germany's coramaze receives $5M in Series A to develop transcatheter mitral valve repair device

Germany's coramaze technologies announced that it is receiving €4.5 million ($5.05 million) in a Series A round led by Israel's Elron Electronic Industries, making it the latest player in the burgeoning field of transcatheter mitral valve devices.

St. Jude touts study in support of its fractional flow reserve cardiology tech

At the European Society of Cardiology Congress in London, St. Jude Medical touted the 5-year results of a trial of its fractional flow reserve (FFR) devices. The company said use of its FFR technology results in improved clinical decision making during percutaneous coronary interventions, such as stent implantation.

Medtronic finds gene that predicts sudden cardiac death, IDs need for implantable defibrillator

Medtronic announced at the European Society of Cardiology Congress in London that a study conducted by the Cedars Sinai Heart Institute has identified a genetic variation associated with sudden cardiac death, which can be prevented using implantable cardioverter defibrillators.

Quanterix and Banyan Biomarkers forge ahead with brain injury diagnostic tech

As the med tech industry zeroes in on noninvasive tests that rapidly diagnose concussions, Quanterix and Banyan Biomarkers are joining forces to develop products that could provide a new standard of care for patients.

Precedent from Amarin's off-label promotion victory covers devices too, especially those marketing a surrogate endpoint

A recent court ruling inhibiting the FDA from punishing Amarin for off-label promotion deemed truthful and non-misleading shook up the pharma world. The ruling was made for reasons "totally extrinsic to the definition of a drug," and its principles "definitely apply to medical devices," said attorney Coleen Klasmeier in an interview. She heads the food, drug and medical device regulatory practice team at Sidley Austin LLP.

Google pairs with Sanofi for diabetes monitoring collaboration

Google is teaming up with French drugmaker Sanofi for a diabetes monitoring collaboration, furthering the tech giant's foray into medical devices and its commitment to developing innovative products for the disease.