Medtronic secures Medicare coverage and FDA nods for MiniMed 780G system
Medtronic’s MiniMed 780G system with Abbott’s Instinct sensor now qualifies for Medicare coverage, giving beneficiaries access to its 15-day wear continuous glucose monitoring solution. The FDA also approved integration with ultra rapid-acting insulins Fiasp and Lyumjev and cleared the system for insulin-requiring Type 2 diabetes.
1. Medtronic to Acquire CathWorks in Strategic $585 Million Deal
Medtronic announced an agreement to acquire privately held CathWorks for up to $585 million, reinforcing its position in interventional cardiology diagnostics. CathWorks’ proprietary FFRangio™ technology noninvasively assesses coronary blood flow using angiographic images, addressing an estimated 5 million diagnostic catheterization procedures performed annually in the U.S. The acquisition is expected to close by mid-2026, pending regulatory approvals, and will integrate CathWorks’ solutions into Medtronic’s commercial infrastructure across 160 countries. Management projects the deal will be accretive to adjusted earnings per share within 12 months and anticipates incremental annual revenue growth of $50 million by 2028 as hospitals adopt physiology-based lesion assessment to improve patient outcomes and reduce the need for invasive pressure wires.
2. Diabetes Division Unlocks New U.S. Access and FDA Clears Additional Therapies
Medtronic Diabetes secured three U.S. milestones enhancing its MiniMed™ 780G automated insulin delivery platform. First, Medicare and Medicare Advantage beneficiaries now have access to the MiniMed™ 780G system paired with Abbott’s Instinct™ sensor, which offers up to 15 days of continuous glucose monitoring. Second, the FDA granted clearance for ultra rapid-acting insulins Fiasp® and Lyumjev® to be used with the 780G system, enabling faster mealtime control and potentially reducing post-prandial glucose spikes. Third, the MiniMed™ 780G was cleared as an interoperable automated glycemic controller for insulin-requiring type 2 diabetes, expanding its addressable market by approximately 1.5 million additional patients in the U.S. Medtronic expects these approvals to drive double-digit growth in its diabetes segment in fiscal 2027, as reimbursement expands and clinicians adopt more flexible, data-driven therapy options.