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 updated its final guidance to clarify use of the Breakthrough Devices Program in advancing health equity. The voluntary program was created to speed up the process of getting innovative medical devices to patients that treat life-threatening or debilitating diseases.