
Abbott wins FDA clearance for duo of over-the-counter CGMs
Abbott (NYSE: ABT)+ today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio.

Abbott (NYSE: ABT)+ today announced FDA clearance for two over-the-counter continuous glucose monitor (CGM) systems, Lingo and Libre Rio.

Abbott (NYSE: ABT)+ has secured a 510(k) clearance from the FDA for its over-the-counter Lingo glucose-monitoring biowearable.

CamDiab announced today that the FDA granted authorization for its CamAPS FX advanced adaptive closed-loop artificial pancreas app.

Outset paused shipments of its TabloCart with prefiltration last year after receiving a warning letter from the FDA.

MyKidneyAI Becomes the Company’s Second Innovation to Recently Receive this FDA Distinction

The first fully implantable continuous glucose monitors can now be integrated with insulin pumps as part of an automated insulin delivery system

Sequel Med Tech will sell the new system, which integrates with Tidepool’s Loop insulin dosing algorithm.

The FDA’s decision allows people who don’t take insulin, including those who don’t have diabetes, to use the devices without a prescription.

Dexcom (Nasdaq:DXCM) announced today that the FDA cleared its Stelo glucose biosensor that does not require a prescription.

Glaukos (NYSE:GKOS) announced today that the FDA approved a New Drug Application (NDA) for its iDose TR implant.