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January 12, 2026
1 min read
Key takeaways:
- The MiniMed Go app received FDA 510(k) clearance for people with type 1 or type 2 diabetes requiring insulin.
- The app will connect to the MiniMed Go to provide real-time insulin dosing data to users.
Editor’s note: This is a developing news story. Please check back soon for updates.
The FDA has cleared a mobile application that will connect with a next-generation multiple daily injection automated insulin delivery system, according to an industry press release.
Medtronic Diabetes announced that the FDA has granted 510(k) clearance for the MiniMed Go app for children and adults aged 7 years or older with type 1 or type 2 diabetes who require insulin as well as children aged 2 to 6 years with diabetes under supervision of an adult caregiver.
According to the press release, the app will connect to the MiniMed Go Smart multiple daily injection system (Medtronic) to provide real-time data to users. The MiniMed Go Smart system integrates with the InPen smart insulin pen (Medtronic) as well as the Instinct continuous glucose monitoring sensor (Abbott). Some of the information that the app will provide includes missed dose alerts, an insulin dosing calculator, guidance in the event a user misses or miscalculates a dose and software for collaborating with a health care professional.
“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,” Que Dallara, executive vice president and president of Medtronic Diabetes and CEO-designate of MiniMed, said in a press release. “MiniMed Go is designed to change that — bringing the smarts of an automated insulin delivery system to individuals who prefer an insulin pen. The system helps take the guesswork out of multiple daily injection therapy, delivering simplicity and confidence in every dose.”
According to the press release, the FDA is currently reviewing compatibility of the Simplera sync sensor with the MiniMed Go system. MiniMed Go is expected to launch in spring 2026 in the U.S., according to the release.
Sources/Disclosures
Source:
Disclosures:
Dallara is an employee of Medtronic Diabetes.
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