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Beta Bionics has received U.S. Food and Drug Administration clearance for the Mint wearable insulin pump, which is worn for three days and holds 200 units of insulin. The company plans to launch it in the United States during the first quarter of 2027 through pharmacy channels, opening direct competition with Insulet.
CDRH has launched a reference portal explaining regulatory reliance programs for assessments and decisions by other regulatory authorities, focusing on using FDA data without transferring decision-making responsibility or reducing safety requirements. The portal provides guidance on verifying the identity of devices and their manufacturing sites and monitoring post-market safety.