Medtronic announced that its MiniMed Go™ Smart Multiple Daily Injection (MDI) system has received U.S. Food and Drug Administration 510(k) clearance. The system pairs the company’s reusable InPen smart insulin pen with Abbott’s Instinct continuous glucose sensor and connects them through the MiniMed Go app, delivering real‑time glucose data, automated dose calculations, missed‑dose alerts, and actionable guidance for patients with insulin‑requiring type 1 or type 2 diabetes.
The clearance opens a sizable addressable market of more than 15 million people worldwide who rely on multiple daily injections. The Instinct sensor, which can be worn for up to 15 days, gives the system a competitive edge over other CGMs that require daily sensor changes. Abbott’s Simplera sensor, also compatible with the MiniMed Go platform, is currently under FDA review, and its approval would further broaden the system’s appeal to users who prefer a single‑sensor solution.
Medtronic’s diabetes segment has shown double‑digit growth in recent years. Revenue was $2.488 billion in FY 24 and rose to approximately $2.8 billion in FY 25, an 11% year‑over‑year increase. Q4 FY 25 revenue reached $728 million, up 12.0% organically, driven by strong demand for the MiniMed 780G system and the new Smart MDI platform. The segment’s momentum underscores the commercial potential of the MiniMed Go system and supports Medtronic’s broader strategy of expanding its diabetes portfolio before the planned spin‑off of the Diabetes division into a standalone company named MiniMed by mid‑ to late 2026.
The FDA clearance is a key milestone in Medtronic’s transition toward a direct‑to‑consumer model for its diabetes products. By offering a fully integrated, pen‑based solution that delivers many of the benefits of automated insulin delivery, Medtronic can capture a larger share of the growing insulin‑pen market and position the future MiniMed company as a leader in smart diabetes care. The clearance also strengthens Medtronic’s revenue base ahead of the spin‑off, providing a more robust platform for the new entity to pursue growth opportunities.
Geoff Martha, Medtronic Chairman and CEO, said the company’s “strong earnings power and continued double‑digit growth in the diabetes segment” are evidence of the company’s “ability to execute on its strategy.” Que Dallara, EVP and President of Medtronic Diabetes and CEO‑designate of MiniMed, added that the MiniMed Go system “brings the smarts of an AID system to individuals who prefer an insulin pen, removing guesswork from MDI therapy.”
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