News

J&J's Ethicon gets FDA clearance to use Evarrest patch for liver surgery

Johnson & Johnson's Ethicon division received clearance from the FDA for an expanded indication of its Evarrest patch, which can now be used to help control bleeding during adult liver surgery.

Fierce 15 company Infraredx cancels planned IPO

Fierce 15 member Infraredx backed out of its planned $56 million IPO, citing "unfavorable market conditions."

Experts: Stent retrieval devices to play larger role in treatment of stroke

Earlier this year, four new studies showed that stent retrieval devices to physically remove blood clots in the brain can save stroke patients' lives.

U.S. health insurers consider new curbs on morcellators amid regulatory pushback

U.S. health insurers are joining a swelling chorus of discontent over power morcellators, limiting the products or considering new restrictions a year after the FDA warned against using the devices in certain gynecological procedures.

Medtronic pays feds $4.4M over DOJ allegations that it falsely labeled devices as made in the USA

Medtronic agreed to pay $4.4 million to settle a Department of Justice lawsuit claiming that the company mislabeled imported devices as made in the USA so that it could sell them to the U.S. military.

Medtronic grabs artificial pancreas tech from Israeli devicemaker

Medtronic snatched up artificial pancreas technology from Israel-based DreaMed Diabetes for its insulin pumps, the company's latest deal as it looks to diversify its diabetes offerings and cash in on a growing market.

The top companies in med tech: 2014 revenue results

Big med tech companies have been making big moves to transform themselves this year. These changes will undoubtedly make our 2015 top med tech revenue list look substantially different from this one.

Lux Capital closes new $350M VC fund focused on science, devicemakers

Lux Capital, a 15-year-old investment firm, raised $350 million for a new venture fund targeted at science and healthcare startups like devicemakers 3Scan and SOLS, the company said in a blog.

FDA to investigate Bayer's birth control device after allegations of fraud during clinical trial

The FDA has agreed to investigate Bayer's Essure birth control device, following complaints of fraud during the clinical trial and dangerous side effects.

Philips stumbles again in CT manufacturing as FDA reveals a recall

Royal Philips is working to get its manufacturing of computed tomography (CT) systems back up and running. It recently said it would resume shipments of CT systems from its Cleveland, OH, facility--but now the FDA has issued a class 2 recall for CT systems from that same location.

Medtronic expands services push to diabetes care with acquisition of Diabeter

Med tech company executives often talk about the need to provide not just products but "solutions" to problems like meeting Affordable Care Act metrics at hospitals and lowering the cost of patient care. Now, Medtronic is expanding its push into healthcare services to a new front with the acquisition of the Netherlands' diabetes and research clinic Diabeter.

Israeli scientist developing novel wound-closing laser

An Israeli scientist is developing a system to close wounds and surgical incisions via laser beam.

Boston Scientific buys endoscopic ultrasound pancreatic treatment startup for $75M+

Boston Scientific added to an existing strength in endoscopy by acquiring Xlumena for up to $75 million plus undisclosed sales milestones.

Medtronic tries again in renal denervation after previous trial failure

In the device world, "Symplicity" is synonymous with complexity and spectacular failure, after the surprising and miserable results from Medtronic's Symplicity HTN-3 clinical trial of its (supposedly) hypertension lowering renal denervation device. Despite the setback, the company is trying again.

Roche celebrates promising study results for fetal blood test

Roche is touting results from a new study that shows its fetal blood test for Down syndrome works better than traditional screening tests in younger, low-risk pregnant women, a potential boon for the company as it looks to gain ground in a fiercely competitive prenatal testing market.

App enabling iPhone to function as hearing aid launched

Jacoti is kicking off the launch of its smartphone-enabled hearing aid, ListenApp. It modifies the sound using software installed into an iPhone.

NuVasive CEO departs amid allegations of expense, personnel irregularities

Alexis Lukianov has resigned as CEO of minimally invasive surgical spine player NuVasive due to violations of the company's expense reimbursement and personnel policies. The amounts involved are said to be immaterial to the company's financial results. The allegations are a result of an independent investigation that was overseen by the NuVasive board.

Pilot program deploying COPD Navigator app launched with participation of Mount Sinai hospital

An app compatible with Apple's HealthKit launched a pilot program with New York City's Icahn School of Medicine at Mount Sinai, in attempt to help patients self-manage COPD.

Baxter gets CE mark for connected, at-home dialysis system

The latest CE-marked peritoneal dialysis system from Baxter has two-way connectivity that enables healthcare providers to monitor home treatments and adjust them remotely as necessary. The system, called HomeChoice Claria with ShareSource, is expected to reduce manual data input by patients and clinics.

Orthofix restates earnings, gains option to buy migraine device startup eNeura for $65M+

Orthofix has secured an 18-month option to buy eNeura with a $15 million loan. The financing is designed to support the commercialization of the startup's Spring TMS device that FDA cleared last May and is the first portable device available in the U.S. to treat acute pain associated with migraine headache with aura, according to the company.