Medtronic Receives FDA Approval for Smart Insulin App Suite Combining InPen and Simplera CGM

Medtronic has secured FDA clearance for its Smart MDI system, which integrates the InPen smart insulin pen with the new Simplera continuous glucose monitor. This innovative system is designed for people who manage diabetes with multiple daily insulin injections, offering real-time, personalized insights into insulin dosing. By providing corrective recommendations for missed or inaccurate doses, the system aims to prevent glucose spikes and enhance diabetes management. The InPen sends dosing data to a smartphone app, which calculates insulin needs based on glucose readings and carb intake[1]. This comprehensive approach provides a proactive solution for maintaining stable blood sugar levels and is set to first launch to existing users before a broader rollout takes place[2].