FDA Clears Medtronic’s MiniMed Go App Linking InPen With Abbott’s Instinct CGM

Overview

• The 510(k) clearance covers insulin-requiring people with type 1 or type 2 diabetes, including those aged 7 and older and children 2 to 6 under adult supervision.
• The app connects the InPen smart insulin pen with Abbott’s Instinct continuous glucose monitor to provide real-time dosing guidance, missed-dose alerts, and a dose calculator.
• Users receive action-oriented prompts after missed or miscalculated doses, and clinicians can access CareLink reports for collaboration.
• The clearance extends automated insulin delivery–style decision support to people using multiple daily injections rather than pumps.
• Medtronic’s collaboration with Abbott began in 2024 and already includes pairing the Instinct sensor with the MiniMed 780G automated insulin delivery system.