FDA Clears Medtronic MiniMed Go Smart MDI System

Reuters
2026.01.12 14:01
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Medtronic plc has received FDA 510(k) clearance for its MiniMed Go™ Smart MDI system, which combines the InPen™ smart insulin pen and Abbott's Instinct sensor, connected via the MiniMed Go™ app. This system is approved for individuals aged 7 and older with insulin-requiring type 1 and type 2 diabetes, and for children aged 2 to 6 under adult supervision. The commercial launch is expected in the U.S. this spring, with the Simplera™ sensor's compatibility currently under FDA review.