FDA Clears First Over-the-Counter Continuous Glucose Monitor for Diabetes Patients

Dexcom received FDA clearance for Stelo, an over-the-counter continuous glucose monitor (CGM) for Type 2 diabetes patients who do not use insulin. It is the first glucose biosensor that does not require a prescription, scheduled for online release in summer 2024. Stelo uses sensors on the upper arm to provide real-time glucose tracking wirelessly to smartphones. Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, praised the clearance for expanding access. Jake Leach, COO of Dexcom, expressed commitment to making Stelo widely accessible. Dexcom shares rose over 2% in extended trading.

Dexcom received FDA clearance for Stelo, an over-the-counter continuous glucose monitor (CGM) for Type 2 diabetes patients who do not use insulin. It is the first glucose biosensor that does not require a prescription, scheduled for online release in summer 2024. Stelo uses sensors on the upper arm to provide real-time glucose tracking wirelessly to smartphones. Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, praised the clearance for expanding access. Jake Leach, COO of Dexcom, expressed commitment to making Stelo widely accessible. Dexcom shares rose over 2% in extended trading.

Dexcom received FDA clearance for Stelo, an over-the-counter continuous glucose monitor (CGM) for Type 2 diabetes patients who do not use insulin. It is the first glucose biosensor that does not require a prescription, scheduled for online release in summer 2024. Stelo uses sensors on the upper arm to provide real-time glucose tracking wirelessly to smartphones. Dr. Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, praised the clearance for expanding access. Jake Leach, COO of Dexcom, expressed commitment to making Stelo widely accessible. Dexcom shares rose over 2% in extended trading.

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