Under pressure from patients and the FDA, Cigna (NYSE:CI) and Express Scripts said today that they will lower the price of insulin to $25 per month for some patients. Three firms — Eli Lilly, Novo Nordisk and Sanofi — control 90% of the global insulin market and produce all the insulin used in the U.S. […]
FDA wants public input on AI-enabled device regulation
The FDA today floated some ideas on how it might regulate medical devices armed with artificial intelligence — also known as software-as-a-medical-device (SaMD) — whose algorithms can change based on machine learning (ML) and possibly affect people in ways for which they were not approved or cleared. It is also asking for the public’s feedback. To date, […]
Medigate spreads into healthcare IOT
Medical device security firm Medigate said today that it is expanding into clinical IoT and general IoT devices. The company developed and supports a medical device security and asset management platform designed to identify, tag and fingerprint individual medical devices beyond their IP address. Tags for devices are based on type, vendor and model, and allow for […]
Medical Alley companies beat Q1 investment total
A surge in first-quarter 2019 investments in Medical Alley Association member startups pushed them past their performance in the same quarter last year, according to the Minnesota-based trade group. Seven of the 10 largest raises of the quarter went to medical device companies, which propelled the sector to its best first quarter on record, nearly doubling the […]
3M debuts long-wearing medical adhesive
3M (NYSE:MMM) said that it has added an extended-wear medical transfer adhesive to its lineup of advanced adhesives for medical devices. Designed to laminate many substrates, 3M medical transfer adhesive 4075 features an extended-wear pressure sensitive-transfer adhesive and allows design engineers to use a variety of backings. The new adhesive also offers up to a 14-day […]
S&P boosts Integer Holdings’ outlook
Integer Holdings (NYSE:ITGR) said it has received a positive outlook and a reaffirmed B+ long-term issuer credit rating from Standard & Poor’s (S&P). The positive outlook, which was revised from stable, is based on Integer’s debt reduction and expected future targeted debt-to-adjusted EBITDA leverage ratio between 2.5X – 3.5X. S&P also cited Plano, Texas-based Integer’s customer […]
Treace Medical touts results of bunion surgery study
Treace Medical Concepts said a study of its bunion implant surgery showed a high healing rate in patients undergoing an accelerated recovery protocol. The study of the Ponte Vedra, Fla.-based company’s Lapiplasty 3D bunion correction system showed that most patients were able to stand on their operative foot five days after surgery and had a […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
First U.S. patient treated with Cook Medical endovascular aortic dissection system
Cook Medical has launched its Zenith dissection endovascular system, recently approved by the FDA. The first patient was treated with the system at Cooper University Health Care in Camden, N.J., Cook Medical announced yesterday. The Zenith system was designed to provide physicians with a less-invasive alternative to open surgery for repair of Type B dissections of […]
ECRI Institute to open international medtech testing lab in Malaysia
ECRI Institute said it is launching its first medical device evaluation laboratory outside the United States. The ECRI International Research Centre in Selangor, Malaysia will evaluate medical devices used across all care settings in Europe and Asia to help medical professionals make informed decisions that improve patient safety, according to the nonprofit, independent organization. It is […]
Bayer loses bid to toss some claims in Essure class action suit
A federal judge in Philadelphia will allow six women who are suing Bayer (ETR:BAYN) over its Essure sterilization implant to proceed with their personal injury claims and three others to pursue their breach-of-warranty claims. One woman who became pregnant following implantation with Essure will be able to pursue her claim that Bayer fraudulently concealed the […]