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Bookmark or Share- Breaking: FDA Clears Dexcom Stelo, First OTC Continuous Glucose MonitorThe FDA has cleared the Dexcom Stelo Glucose Biosensor System as the first OTC continuous glucose monitor (CGM). The device is an integrated CGM intended for use in adults aged 18 years and older who do not use insulin or in those without diabetes who wish to better understand how diet and exercise affect blood glucose levels. 1
- Dexcom Submits New CGM for Non-Insulin Type 2 Diabetes for FDA ClearanceUnlike other CGM technologies often catered toward patients with type 1 diabetes (T1D), Stelo was designed with the needs of patients with type 2 diabetes (T2D) in mind. Streamlined for this patient population, Stelo will measure blood glucose data for 15 days instead of 10 and omit insulin-related alarms, resulting in a shorter warmup time for ...
- Abbott’s OTC Lingo CGM for Wellness Now AvailableFollowing clearance by the FDA in June of this year, Abbott has announced the availability of Lingo, the company’s first continuous glucose monitoring (CGM) system available without a prescription, in a news release. 1 The wearable is intended for consumers 18 years and older who are interested in improving their overall health and wellness and is not intended for diagnosis of diseases ...
- FDA Approves 2 New OTC Continuous Glucose Monitors - Drug TopicsThe FDA has provided clearance to 2 over-the-counter (OTC) continuous glucose monitor (CGM) systems, health care technology company Abbott announced in a release. 1 The new OTC devices are based on the company’s FreeStyle Libre sensing technology, which is the most widely used CGM system in the world.
- Dexcom’s OTC Continuous Glucose Monitor Now Available in US - Drug TopicsThe Stelo glucose biosensor system was approved by the FDA in March 2024. The integrated CGM is intended for use in adults aged 18 years and older who do not use insulin or in those without diabetes who wish to better understand how diet and exercise affect blood glucose levels. 2 The approval was based on data from a clinical study that demonstrated the Stelo performed similarly to other ...
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