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