FDA clears Medtronic’s new smart diabetes management app
Medtronic has received U.S. Food and Drug Administration (FDA) clearance for the MiniMed Go Smart Multiple Daily Injection system.
MiniMed Go is the company’s new smart diabetes management app that integrates the InPen smart insulin pen with the Instinct sensors manufactured by Abbott. It was designed to provide users with real-time health data and recommendations. The FDA’s clearance covers individuals ages 7 years old and older with insulin-requiring type 1 and type 2 diabetes. It is also cleared for children between the ages of 2 and 6 years old under adult supervision.
“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, an executive vice president and president of Medtronic’s diabetes division. “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.”
Medtronic and Abbott first announced their new partnership in 2024, highlighting the importance of working together to improve care for patients with type 1 and type diabetes. Medtronic’s MiniMed 780G system integrated with Abbott’s new Instinct sensors gained FDA approval in September 2025 and then officially launched two months later.
Key approval announced as Medtronic’s diabetes business prepares to go public
Medtronic recently confirmed that its diabetes division had filed the necessary paperwork with the U.S. Securities and Exchange Commission (SEC) to go public with Dallar as its CEO. The new entity will operate under the name MiniMed, which was also the original name of Medtronic’s diabetes business before it was acquired in 2001.
MiniMed will be traded on Nasdaq under the symbol MMED.
“As we become a standalone company, we are rebuilding MiniMed with the discipline of a public company and the relentless drive of a startup,” Dallara said in the company’s SEC filing. “We continue to design our products and brand with the same care that people bring to managing their health.”
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.