Want to get mHealth and other medical devices into seniors’ homes? Best Buy (NYSE:BBY) and its Geek Squad may be the way in the door. “For companies looking to bring healthcare interactions into the home, we could be a fairly useful partner,” Asheesh Saksena, president of Best Buy Health, told hundreds of medical device industry […]
Enclear Therapies wins novel device challenge
EnClear Therapies’ system designed to treat amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases was one of five first-place winners of the Massachusetts Life Sciences Center (M2D2) $200K Challenge. Cambridge, Mass.-based EnClear Therapies’ device-based system was designed to halt the progression of neurodegenerative diseases by removing toxic proteins that build up in the brain and […]
Boston Scientific wins FDA approval for Lotus Edge TAVR
Boston Scientific (NYSE:BSX) said yesterday that it won pre-market approval from the FDA for its Lotus Edge transcatheter aortic valve replacement for high-risk patients. Marlborough, Mass.-based Boston Scientific touted the device as the only TAVR on the U.S. market designed to be repositioned or recaptured after deployment. The path to PMA wasn’t an entirely smooth one; […]
UPDATE: Stryker shares steady on Street-beating Q1
Updated to include recent share value changes for Stryker Shares in Stryker (NYSE:SYK) are trading steady after the medical device maker posted first quarter 2019 earnings that topped expectations on Wall Street. The Kalamazoo, Mich.-based company posted profits of $412 million, or $1.09 per share, on sales of approximately $3.52 billion for the three months ended […]
BaroNova wins FDA nod for TransPyloric Shuttle weight loss device
BaroNova said today that it won FDA approval for its TransPyloric Shuttle non-surgical device intended for treating obesity, now cleared as a weight loss solution for adults with obesity and a body mass index of 30 to 40 kg/m2. The San Carlos, Calif.-based company said that the device is approved for up to 12 months […]
Presbia abandons Flexivue microlens, lays off all but 3
Presbia (NSDQ:LENS) yesterday said it spiked its Flexivue microlens development program in the face of FDA headwinds, laying off all but three of its employees as it seeks investors to bail it out. Earlier this month the Irvine, Calif.-based company delayed the pre-market approval timeline for Flexivue, which is designed to treat far-sightedness or presbyopia, after […]
TransMedics sets IPO range with $75m midpoint
TransMedics yesterday set the range on its forthcoming initial public offering, which would gross more than $75 million at the midpoint. Andover, Mass.-based TransMedics developed a transportation system for organ transplants that’s designed to keep donated hearts, lungs and livers in near-living condition until transplantation. A year ago TransMedics won pre-market approval from the FDA […]
FDA Form 483s could get easier for medical device companies: Here’s how
FDA in the U.S. is setting up a formal way for medical device companies to get nonbinding feedback about Form 483s, which raise potential manufacturing process problems. FDA is taking comments through today about the draft guidance, which it issued Feb. 19 under a requirement in the FDA Reauthorization Act of 2017. The proposed process […]
NuVasive touts results of PEEK implant study
NuVasive (NSDQ:NUVA) today announced the results of a study that showed its Cohere porous polyetheretherketone (PEEK) implant improved early outcomes over structural allograft and smooth PEEK in anterior cervical discectomy and fusion (ACDF) procedures. In the study of 167 patients with degenerative cervical disc disease, those who underwent ACDF using Cohere porous PEEK exhibited significant […]
Axogen shares slip on expanded Avance nerve graft study
AxoGen (NSDQ:AXGN) today expanded a study of its Avance graft for treating peripheral nerve damage on a pre-specified statistical analysis, sending its share price down slightly today. Alachua, Fla.-based AxoGen is adding 50 patients and five new centers to the Recon study of Avance, a human allograft designed to bridge severed nerves without a second surgical […]
Pothole jars man’s racing heart back to normal
Hitting a pothole can save your life, even if it wrecks your alignment. A 59-year-old Nebraska man who was being transported to the hospital for a rapid heartbeat had his heart jolted back into a normal rhythm when the ambulance hit a pothole, according to published reports. The man was at work when his heart […]
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