No More Carb Counting: FDA Clears Next Generation Insulin Pump
The US FDA granted 510(k) clearance to Beta Bionics iLet ACE Pump and dosing decision software for treating type 1 diabetes with less diet monitoring.
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Market Intel: Bigfoot Biomedical, Beta Bionics Getting Pumped To Introduce Next-Gen Artificial Pancreas
The insulin pump market, which is dominated by four major players, is facing rising competition from smaller, innovative companies. This second part of a two-part series focuses on five emerging companies: Beta Bionics, Bigfoot Biomedical, Diabeloop, EOFlow and Ypsomed.
News We’re Watching: Disease X Act, Abiomed Recall, TAVR AI Cleared
This week, the bipartisan Disease X Act for pandemic preparedness was introduced in the US House of Representatives; Abiomed Impella pumps were the subject of a class I recall; Dasi Simulations and Endologix landed FDA clearances; and the FDA warned against the use of Getinge/Maquet Oxygenators.
FDA Seeks Feedback On Attempt To Modernize Clinical Trials
The US FDA has released a draft guidance from the International Council for Harmonisation that aims to modernize clinical trials. The agency is requesting feedback on the draft, which includes updates on good clinical practices.