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.

Selected current and forthcoming diabetes devices - in-house
Company	Technology	Type	Status
Abbott	Freestyle Libre 3	CGM	CE marked Sep 2020; FDA approved May 2022
Dexcom	G7	CGM	CE marked Mar 2022; FDA approved Dec 2022
Insulet	Omnipod 5*	Insulin pump	FDA approved Jan 2022; CE marked Sep 2022
Tandem	t:slim X2	Insulin pump	FDA approved Aug 2017; CE marked Apr 2018
Tandem	t:slim X3	Insulin pump	In development
Tandem	Mobi	Insulin pump	Awaiting FDA approval
Ypsomed	Mylife YpsoPump	Insulin pump	CE marked Jun 2016; FDA filing planned for H2 2023
Medtronic	Minimed 770G	Closed-loop	FDA approved Aug 2020; CE marked
Medtronic	Minimed 780G	Closed-loop	CE marked Jun 2020; awaiting FDA approval
CGM = continuous glucose monitor. *Formerly called Omnipod Horizon. Source: company communications, analyst notes.

 

Selected current and forthcoming diabetes devices - collaborations
Companies	Technology	Status
Insulet/Dexcom	Omnipod 5* with G6	Approved US Jan 2022
Insulet/Dexcom	Omnipod 5 with G7	Expected 2022 or 2023
Insulet/Abbott	Omnipod 5 with Freestyle Libre 2	Expected 2023
Insulet/Abbott	Omnipod 5 with Freestyle Libre 3	Expected 2023
Ypsomed/Abbott	Mylife YpsoPump with FreeStyle Libre 3	Expected 2023
Tandem/Dexcom	t:slim X2 with G6	FDA approved and CE marked Dec 2019
Tandem/Dexcom	t:slim X2 with G7	Expected 2022 or 2023
Tandem/Abbott	t:slim X2 with Freestyle Libre 2	Expected 2022
Tandem/Abbott	t:slim X2 with Freestyle Libre 3	Expected 2022 or 2023
*Formerly called Omnipod Horizon. Source: company communications, analyst notes. https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/medtronic-left-behind-new-class-glucose