News

Plaintiffs' lawyers dismiss J&J's latest claim as vaginal mesh litigation drags on

In the latest act of the vaginal mesh litigation drama, plaintiffs' lawyers disputed J&J's claims that fishy phone calls recruiting women to file vaginal mesh-related suits are tainting the legal process and deserve further investigation.

GE Healthcare says strong U.S. growth offset weakness abroad

GE touted the strength of its healthcare business in the U.S., saying the country compensates for slowing growth in countries like Japan and Russia and is a headwind against unfavorable exchange rates abroad.

FDA approves next-gen Medtronic device to treat drug-refractory gastroparesis

The FDA has approved a second-generation Medtronic device to treat gastroparesis patients who are not able to control nausea and vomiting using drugs. The Enterra II System has been approved under a humanitarian device exemption, which is used by the agency to approve devices intended for a population of fewer than 4,000 people in the U.S.

Nevro gains on FDA pending approval with the resolution of manufacturing, labeling issues

Recent med tech IPO success story Nevro has garnered an approvable letter from the FDA for its Senza spinal cord stimulation system to treat chronic pain, according to the company. Nevro said it needs to address manufacturing and product labeling issues in order to attain FDA approval.

Profit down 12% at Intuitive Surgical, but procedure volume up due to strength abroad and in general surgery

Procedures conducted using Intuitive Surgical's da Vinci robot rose 9% in 2014, on the back of strong growth in general surgery, CEO Gary Guthart said during the company's fourth quarter earnings call.

bioMérieux and Astute Medical join forces on acute kidney injury test

French in vitro diagnostics outfit bioMérieux and Astute Medical are teaming up to develop Astute's test for acute kidney injury, continuing the companies' recent diagnostics winning streak and helping them capitalize on a growing market.

FDA's device arm issues strategic priorities for 2015

The FDA's device arm (CDRH) just issued its strategic goals. They are: to strengthen the clinical trial enterprise, to strike the right balance between premarket and postmarket data collection and to provide excellent customer service.

GERD transoral surgical startup releases sham-controlled data as it awaits reimbursement code

EndoGastric Solutions is awaiting the outcome of a CPT code meeting to enable payer reimbursement for its transoral gastroesophageal reflux disease (GERD) surgical device within the next few weeks. In the meantime, the startup has released data on the transoral incisionless fundoplication (TIF) procedure in the latest issue of the journal Gastroenterology.

J&J, Boston Sci present closing arguments in 10-plus-year legal spat over Guidant

A titanic struggle is nearing its end. Rivals Boston Scientific and Johnson & Johnson are done presenting their arguments in a legal spat involving the disastrous 2005-2006 bidding war and purchase of cardiology player Guidant. The purchase threatens to become an even worse decision for acquirer Boston Scientific, which would owe $7.2 billion if J&J gets its way.

K2M to cash out shareholders, raise $40M on FDA nod for next-gen spinal system

K2M Group Holdings got FDA clearance for the second generation of its top product, the Mesa Deformity Spinal System. The company is now planning to capitalize on that milestone. It's slated to raise $40 million, as well as to sell 4.9 million on behalf of existing shareholders including its majority owner, private equity group Welsh, Carson, Anderson & Stowe.

China announces landmark medical device GSP rules

SINGAPORE--China's FDA has issued the country's first GSP (Good Supply Practices) rules that will cover 1, 2 and 3 medical device distributors, as it moves to harmonize practices followed elsewhere in the world and rein in service providers of medical devices that may not have detailed technical expertise.

Welch Allyn buys eye exam provider, signaling move into services

Welch Allyn expanded its focus on point-of-care devices with its acquisition of Hubble Telemedical, a provider of diabetic retinopathy screening in primary care settings.

J&J settles the score with over 100 vaginal mesh plaintiffs

One week after Johnson & Johnson said that women were being illegally solicited by unknown callers to sue over the company's transvaginal mesh devices, J&J has agreed to settle more than 100 product liability lawsuits regarding pelvic mesh products sold by its Mentor subsidiary.

What did President Obama mean by 'precision medicine' in the State of the Union?

What exactly was President Obama talking about when he said, "Tonight, I'm launching a new Precision Medicine Initiative to bring us closer to curing diseases like cancer and diabetes--and to give all of us access to the personalized information we need to keep ourselves and our families healthier," during the State of the Union? Well ... no one is quite sure yet, but the speculation about the imprecise statement has begun.

B. Braun partners with Cohera to sell TissuGlu in some European countries

Medical supply company B. Braun will be selling the surgical adhesive TissuGlu from startup Cohera Medical in Germany, Spain and Portugal under a new deal. The product received an approvable letter from the FDA in early January. At that time, Cohera said it expected FDA approval within a few weeks, but it hasn't come through quite yet.

Cheetah Medical reveals promising study results for noninvasive blood monitoring tech

Noninvasive hemodynamic monitoring company Cheetah Medical is touting results from a new study showing that using the company's technology to assess fluid responsiveness could save hospitals time and money.

Medtronic's latest MiniMed insulin pump launches in Australia, global rollout planned

Medtronic's MiniMed 640G insulin pump is now available in Australia, with additional launches pending local approval. The company says the device represents the latest march toward the development of an artificial pancreas.

Hospira gets FDA nod for wireless infusion pump, finishing up two-year plan to reinvigorate devices

Hospira hopes to get back on track with its infusion pump business this year. The latest bit of good news for the company is FDA clearance for the Plum 360 Infusion System, which adds the capability to wirelessly stream data to an electronic medical record and access an expanded drug library for information to maintain patient safety.

Top 10 med tech market movers in 2014

A rising tide lifts all boats--that might be the most oft-repeated cliché to sum up market sentiment in the life sciences for the last few years. Biotech performance has been very, very good for three years, and med tech performance, while nowhere near as stellar, has been on its own upward trajectory as investors look for a safer way to make money in healthcare.

NeoTract study: Minimally invasive surgery for enlarged prostate better than conventional version

NeoTract touted study results in the official journal of The American Urological Association that the company claims show that its UroLift device enabling minimally invasive treatment for an enlarged prostate is safe and effective.