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No More Carb Counting: FDA Clears Next Generation Insulin Pump

 
• By Brian Bossetta

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.

FDA CLEARED
• Source: Shutterstock

The Food and Drug Administration on 19 May cleared the way for an automated insulin dosing (AID) system that uses an algorithm to determine insulin delivery for patients with type 1 diabetes.

Together, the Beta Bionics’ iLet ACE Pump and the iLet Dosing Decision Software, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), form an innovative next

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• By Brian Bossetta

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MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

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UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.