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Medtronic wins FDA clearance for MiniMed Go app for InPen smart insulin pen

January 12, 2026 By Sean Whooley

Medtronic MiniMed Go InPen with Abbott Instinct Sensor (1)
The InPen smart insulin pen, Instinct sensor and MiniMed Go app [Image courtesy of Medtronic]
Medtronic (NYSE:MDT) announced today that the FDA granted 510(k) clearance for its MiniMed Go app for multiple daily injections (MDI).

MiniMed Go, a smart MDI system, integrates the InPen smart insulin pen with the Instinct sensor made by Abbott. It all integrates within the app to deliver real-time, personalized insights and actionable guidance.

Medtronic and Abbott entered a collaboration in August 2024 to pair insulin delivery and continuous glucose monitoring (CGM) technologies. Medtronic (soon to be a standalone company called MiniMed) launched the MiniMed 780G automated insulin delivery system with the Instinct sensor made by Abbott late last year.

The Medtronic Diabetes Business is one of the largest diabetes tech companies in the world — learn more about the company and the rest of the diabetes space by downloading our free Diabetes Technology Special Report.

Now, the technology can pair with Medtronic’s other insulin delivery offering, the InPen smart insulin pen. Medtronic said this delivers missed dose alerts to help minimize glucose highs and offers a dose calculator to simplify dose decision-making. It also features action-oriented guidance if a user misses or miscalculates a dose. CareLink software also delivers reporting for easier provider collaboration.

MiniMed Go received clearance for individuals with insulin-requiring type 1 and type 2 diabetes aged seven years and older. It also received the nod for children aged 2-6 under the supervision of an adult caregiver. Compatibility for Medtronic’s own Simplera sensor with MiniMed Go remains under FDA review.

Medtronic expects to launch MiniMed Go in the U.S. in the coming spring.

“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.”

Filed Under: Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Technology Tagged With: FDA, Medtronic, minimed

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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