Medtronic left behind by the new class of glucose monitors

Yesterday’s FDA clearance of Dexcom’s G7 leaves Medtronic alone as one of the big three continuous glucose monitor makers without a next-generation approval this year to its name. Medtronic’s 780G – not strictly a CGM but a hybrid closed-loop system incorporating a CGM as well as an insulin pump – was filed with the FDA in early 2021 but clearance is still likely a way away. The filing suffered a delay a year ago on quality control issues at Medtronic’s diabetes plant; last month the company said it had resolved the issues and was ready for reinspection. Even so, the lag between EU and US approval of the device could be as long as three years. And until clearance eventually arrives, Medtronic is being outplayed in the world’s largest diabetes market not just by Dexcom but by Abbott, whose Freestyle Libre 3 hit the US in late May. As for Dexcom, the next step will be securing reimbursement for the G7, though it will launch next year as a self-pay product. After that work will start on getting approval for combinations with insulin pumps, another important means of securing share of the global CGM market, which Stifel analysts say is worth $3bn.