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Medtronic receives CE mark for CGM sensor, boosting challenge to Abbott and Dexcom

Medtronic has made the sensor smaller and eliminated the need for fingersticks to calibrate the device, bringing a challenger to market leaders Abbott and Dexcom.

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.

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