Medical Device Vendors

Heart devices linked to injuries, deaths receive FDA’s most serious recall

April 18, 2024 - In a recent announcement, the Food and Drug Administration (FDA) revealed that a pair of heart devices, the HeartMate II and HeartMate 3 Left Ventricular Assist System (LVAS), has received the agency's most serious recall classification due to long-term buildup and has been linked to hundreds of injuries and at least 14 deaths. The recall has raised concerns among safety advocates...


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Abbott provided $650,000 to FDA advisory panel members

by Veronica Salib

How should regulatory bodies and consumers weigh payments made by life sciences companies to FDA advisory panel members? That’s the question posed by the recent news that 10 of 14 voting members...

Drawbridge Health’s NanoDrop gains FDA clearance for at-home blood sampling

by Alivia Kaylor

Drawbridge Health, a pioneering healthcare technology company, announced an innovative achievement today as its advanced at-home blood sampling device, NanoDrop Lancet, received United States Food and...

J&J Preps for Consumer Health Spin-Off, Purchases Abiomed for $16.6B

by Hayden Schmidt

Pharmaceutical company Johnson & Johnson struck a deal Tuesday to acquire Abiomed, the heart pump manufacturer. J&J will pay $16.6 billion in cash for the acquisition, valuing the stock at $380...

Beta Bionics Shares Clinical Trial Data on Bionic Pancreas for Type 1 Diabetes

by Veronica Salib

Earlier this month, Beta Bionics presented clinical trial data to the American Diabetes Association (ADA) on its insulin-only bionic pancreas — called the iLet Bionic Pancreas — for use in...