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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After receiving US FDA clearance in May, Beta Bionics secured $100m in financing which is expected to be used to commercialize its iLet Bionic Pancreas and “further develop and test the bi-hormonal bionic pancreas.”
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.
The US FDA has received a significant increase in medical device reports associated with Philips DreamStation 2 machines, including fire, smoke, and burns.