FDA Clears Medtronic's Insulin Delivery System Featuring Abbott Sensor

It expects commercial launch in the U.S. this spring.

Ambar
Medtronic

Medtronic today announced FDA clearance of its MiniMed Go app. The MiniMed Go Smart Multiple Daily Injection (MDI) system integrates the InPen smart insulin pen with the Instinct sensor made by Abbott — all connected through the MiniMed Go app.

The MiniMed Go system is cleared for individuals with insulin-requiring type 1 and type 2 diabetes aged 7 years and older, as well as for children ages 2 to 6 years under the supervision of an adult caregiver. Compatibility of the Simplera sensor with MiniMed Go is currently under FDA review.

"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."

The company expects the commercial launch of the MiniMed Go system to begin in the U.S. this spring.

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