Medtronic Gains Medicare Coverage and FDA Approvals for MiniMed 780G with Instinct Sensor and Ultra-Rapid Insulins
Medtronic received Medicare coverage for its MiniMed 780G pump paired with Abbott’s Instinct CGM sensor, expanding options for beneficiaries. The FDA also cleared the system to use ultra-rapid insulins Fiasp and Lyumjev and for insulin-requiring type 2 diabetes.
1. Medtronic to Acquire CathWorks for Up to $585 Million
Medtronic announced it will exercise its option to acquire CathWorks, an Israeli privately held company specializing in coronary digital health, for an upfront payment of $585 million plus potential undisclosed earn-out payments. The acquisition follows a 2022 co-promotion partnership on the FFRangio System, an AI-driven angiography solution that derives fractional flow reserve values across the coronary tree and provides intraprocedural lesion-optimization tools. The deal is subject to U.S. Federal Trade Commission clearance, expected by the end of Medtronic’s fiscal 2026 year, and is anticipated to be neutral to Medtronic’s fiscal 2027 GAAP and adjusted earnings per share, turning modestly accretive thereafter. Upon closing, CathWorks will operate under the Medtronic umbrella but maintain independent operations until full integration.
2. Medtronic Diabetes Expands Access with Medicare Coverage and New FDA Clearances
Medtronic Diabetes secured three significant U.S. milestones: Medicare and Medicare Advantage coverage for the MiniMed™ 780G system paired with Abbott’s Instinct continuous glucose sensor; FDA clearance to use ultra rapid-acting insulins (Fiasp and Lyumjev) with the 780G algorithm; and FDA clearance of the 780G pump and SmartGuard™ algorithm for insulin-requiring type 2 diabetes in combination with the Instinct sensor. Medicare coverage broadens sensor choice for beneficiaries, who can now select from Instinct, Simplera Sync™, or Guardian™ 4 sensors. The ultra rapid-acting insulin clearance offers faster post-meal glucose control, enhancing automated delivery performance. Expanding the 780G system to type 2 patients addresses an underserved segment with automated glycemic control every five minutes, reducing daily management burden and supporting more stable glycemia.