- Medtronic has received a CE mark for its Simplera continuous glucose monitor, bringing a challenger to Abbott and Dexcom devices in the European Union.
- The device, Simplera, is the successor to the Guardian 4 sensor. Medtronic has made the sensor smaller and eliminated the need to tape it in place to create a CGM that more closely resembles the market-leading devices from its competitors.
- Securing a CE mark could be the first in a series of regulatory milestones for Simplera, with an EU filing for an automated insulin delivery system featuring the sensor under review and work to bring the CGM to the U.S. market underway.
Simplera is central to Medtronic’s diabetes strategy. When the company belatedly won FDA approval for its MiniMed 780G insulin pump earlier this year, analysts at RBC Capital Markets told investors that it “would likely need a smaller sensor like Simplera in order to compete more effectively, and even then it could be an uphill battle as the company has seemingly lost credibility among patients and physicians.”
Medtronic now has a CE mark for the device. The clearance covers an all-in-one, disposable CGM that patients stick to their arms using an application device. No tape is needed to secure the CGM, and no fingersticks are needed to calibrate the device.
Having secured the CE mark, Medtronic plans to start a phased launch at the European Association for the Study of Diabetes annual meeting next week in Hamburg, Germany. Medtronic has yet to receive a CE mark for use of the sensor in its automated insulin delivery system and is focusing on the potential for Simplera to help people who rely on multiple daily injections. Simplera is integrated with Medtronic’s InPen smart insulin pen.
Medtronic CEO Geoff Martha discussed Simplera at an investor conference last week, telling attendees that the adult portion of the U.S. clinical development program is complete and enrollment is underway in children. “Then we'll submit that to the FDA,” Martha said. “We believe that [the] sensor is very competitive.”