
CeQur wins FDA nod for mealtime insulin delivery device
Each patch now replaces up to 12 mealtime injections, equaling more than 1,000 fewer injections annually, according to a news release.

Each patch now replaces up to 12 mealtime injections, equaling more than 1,000 fewer injections annually, according to a news release.

WASHINGTON, June 26, 2024 /PRNewswire/ — MCRA, the leading privately held independent medical device, diagnostics, and biologics Clinical Research Organization (CRO) and advisory firm is pleased to announce its role in aiding CamDiab’s artificial pancreas software, CamAPS FX, in achieving U.S. Food and Drug Administration (FDA) clearance.

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.