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

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.

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.

Get the full story at our sister site, Drug Delivery Business News.

Filed Under: 510(k), Diabetes, Drug Pumps, Drug-Device Combinations, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: FDA, Medtronic, MiniMed

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About Sean Whooley

Sean Whooley is a senior 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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