News

Bayer to sell diabetes device biz for as much as $2.5B

Bayer hopes to sell its ailing diabetes device unit to help bolster growth and fund a potential acquisition of Zoetis. The conglomerate would like to focus more closely on medicines, which has been a faster growth area than devices.

UPDATED: Covidien gets 510(k) for peripheral balloon catheter aimed at hemodialysis patients

Covidien today announced FDA 510(k) clearance for its Fortrex percutaneous transluminal angioplasty balloon catheter, designed to maintain arteriovenous access in hemodialysis patients suffering from chronic kidney disease or end-stage renal failure.

Researchers develop 'Wi-Fi'-triggered dissolvable, implantable device for drug delivery

Researchers at Tufts University have come up with a resorbable electronic implant that when used in mice was able to be triggered remotely by wireless signal and deliver heat to infected tissue.

NxStage launches faster, easier dialyzer for in-center market

NxStage Medical is primarily focused on the at-home dialysis market, but its newest product is devoted to making dialysis treatment in centers easier and faster for providers. It has launched the Streamline Express dialyzer that includes a preattached tubing set expected to reduce machine setup time and potential sites for contamination.

Autism diagnostic app uses smartphone video taken at home

An early-stage study funded by the National Institutes of Health found that diagnosis of autism based on video taken using an in-development smartphone app concurred with diagnosis using  traditional, in-person methods 87% of the time.

FDA cracks down on power morcellator devices in updated safety guidance

Amid growing backlash over tools used in minimally invasive gynecological procedures, the FDA is cracking down on the devices in updated safety guidance.

Reva raises $25M to get CE mark for bioresorbable scaffold

Reva Medical has raised $25 million in debt from Goldman Sachs and Senrigan Capital. The financing had been months in the making and is expected to enable the development-stage company to get its latest bioresorbable stent on the market in Europe.

UPDATED: Stryker said to be interested in buying Smith & Nephew (once again)

The clock is about to strike 6 months since Stryker expressed interest in acquiring Smith & Nephew, only to be dissuaded by a rise in that company's stock price once news of the potential deal broke out. And so begins the speculation that Stryker will actually make a bid on the fellow orthopedics company this time around.

FDA approves Avantis Third Eye device for colonoscopies

The FDA approved Avantis Medical's colonoscopy imaging device that is capable of showing a wide-angle image of more than 300 degrees during colorectal cancer screening procedures.

Tandem partners for open-source software to improve insulin pump data access

Tandem Diabetes Care, the maker of the t:slim insulin pump, has partnered with open-source software provider Tidepool. The deal is expected to better enable diabetes patients using the pump to download and access data from their device.

Smartphone apps to assess mental health based on everyday behavior proliferating

Diagnostic smartphone apps are proliferating. No, these apps don't somehow turn the phone into a needle for drawing blood; instead they monitor stuff we take for granted, like talking or the movement of our eyes.

Gates Foundation backs Ebola trials for plasma-based and other treatments

Blood from Ebola patients who have survived infection has been used to treat patients actively fighting the virus. Now the Bill & Melinda Gates Foundation is backing efforts to test the efficacy of and scale up the production of convalescent plasma and other potential treatments in the field.

Packaging, software issues account for 40% of medical device recalls, report finds

The Q3 2014 Stericycle Recall Index highlights the complexities of medical device recalls in a global economy. With greater technology comes greater responsibility to consumers, and recalls that span different countries and continents add to companies' challenges. Packaging and software issues accounted for 40% of recalls that the Index covered.

FDA delays UDI labeling requirements by two years for some orthopedic devices

The FDA originally proposed requiring implantable medical devices to bear a unique device identification code on their surface. But industry protested that part of the proposed rule, so the agency ultimately opted to rely on packaging as the surface for UDIs. However, some orthopedics are removed from their packaging well before surgery or implantation, forcing the FDA to make a change on the fly.

Boston Scientific ordered to hand over $18.5M in vaginal mesh litigation

Less than a week after Boston Scientific lost its second courtroom battle over vaginal mesh implants, a federal jury ordered the company to pay $18.5 million in damages to four women who claimed the devices caused them constant pain and injuries.

InfoBionic gets $17M to offer cloud-based cardiac monitoring

Mobile cardiac monitoring is one of the most advanced areas in med tech when it comes to wireless, remote tracking of patients. InfoBionic is hoping to take the technology to the next level by combining three different kinds of cardiac arrhythmia monitoring onto a single system that provides real-time, cloud-based patient data.

Study finds hand-held ultrasound device improves diagnosis of heart disease

Medical students who were trained to diagnose valvular heart disease using hand-held echocardiography technology performed better than students trained to diagnose the disease using only traditional methods, such as listening for heart murmurs with a stethoscope.

Boston Scientific's Synergy Stent performs well in pivotal clinical trial

Boston Scientific's Synergy bioabsorbable polymer drug-eluting stent is on track for FDA approval after the successful Evolve II clinical trial, experts said, citing data released yesterday at the American Heart Association meeting in Chicago.

Smith & Nephew closes U.S. facility, sells another in U.K. with 100+ to be laid off

Last week, Smith & Nephew announced it was laying off 108 employees due to the closure of its St. Petersburg, FL, operations, saying the advanced wound care business would be better off if it operated in a single location in Fort Worth, Texas. This week it sold its Gilberdyke, England, factory, saying it would manufacture polyurethane films for its wound dressings from the nearby Kingston upon Hull facility instead.

New paradigms in diagnostics: graphene and a single drop of blood

Philadelphia's Graphene Frontiers is developing a hand-held, point-of-care diagnostic device that can detect heart attack biomarkers from a drop of blood within minutes, thanks to the use of the company's namesake material.