Medtronic announces FDA approval for Simplera CGM and partnership with Abbott

Medtronic (MDT) announced the FDA approval for its Simplera continuous glucose monitor, or CGM, the company’s first disposable, all-in-one CGM that’s half the size of previous Medtronic CGMs. The discreet design simplifies the insertion and wear experience, eliminating the need for overtape. The Simplera platform featuring the company’s newest CGM form factor, includes the Simplera CGM, designed to be used as part of a Smart MDI system with the InPen smart insulin pen and the Simplera Sync sensor, which is designed to be integrated with the MiniMed 780G system. The Simplera CGM and Simplera Sync sensor are CE Marked in Europe and launched earlier this year with positive feedback around ease of use and insertion, adding to the existing high satisfaction with the MiniMed 780G system. The recent FDA approval for Simplera CGM lays the groundwork for future submission of the updated InPen smart insulin pen app, which would facilitate integration with Simplera CGM, as a Smart MDI system. Once FDA clearance is obtained, Medtronic will initiate a limited market release in the U.S. beginning with existing standalone CGM and InPen customers. The Simplera Sync sensor is under review by the FDA in a separate regulatory filing. It is investigational in the U.S. and not approved for commercial use. Additional global regulatory submissions and approvals of the Simplera CGM and Simplera Sync sensor are pending. Medtronic is excited to announce a global partnership with Abbott (ABT) to expand CGM options for people living with diabetes. Under this unique agreement, the companies will collaborate on an integrated CGM based on Abbott’s most advanced CGM platform. Abbott will supply Medtronic with a CGM that will work exclusively with Medtronic smart dosing devices and software across both automated insulin delivery and Smart MDI systems. These systems, including the Abbott-based CGM, will be sold exclusively by Medtronic. Medtronic expects this original equipment manufacturer agreement to be accretive to Diabetes revenue and neutral to Diabetes gross margin. Additional financial terms of the partnership and timing for commercial availability were not disclosed.