Medtronic has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MiniMed Go app.

The MiniMed Go Smart Multiple Daily Injection (MDI) system integrates the InPen smart insulin pen with Abbott’s Instinct sensor, all connected through the MiniMed Go app. The combination provides real-time, personalized insights and actionable guidance.

This includes missed dose alerts to help minimize glucose insights and a dose calculator to simplify dose decision-making. Action-oriented guidance is issued if a user misses or miscalculates a dose. CareLink software also reports for easier collaboration with providers.

Real-world data shows that users of the previous generation Medtronic Smart MDI system had meaningful improvements in glycemic control when consistently responding to actionable alerts. The data showed that Time in Range (TIR) increased from 55.7% to 67.2% when users addressed more than 75% of Missed Dose alerts within an hour, and to 71.5% when users addressed Correct High Glucose alerts with a bolus within an hour.

“For too long, people using injections have carried the weight of diabetes management without access to the algorithms that make automated insulin delivery systems so powerful,” said Que Dallara, EVP and president of Medtronic Diabetes and CEO-designate of MiniMed. “MiniMed Go is designed to change that — bringing the smarts of an AID system to individuals who prefer an insulin pen. The system helps take the guesswork out of MDI therapy, delivering simplicity and confidence in every dose. We’re pleased to expand our full-stack insulin delivery solutions, making it seamless for our customers to find a therapy that works for them—no matter where they are in their journey.”

Last month, the company rolled out its MiniMed 780G system integrated with the Instinct sensor made by Abbott and designed exclusively for MiniMed systems.