
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. |