Fierce Biotech

FDA demands better response from Abbott over Libre inspection violations

Abbott has been hit with a slew of complaints from the FDA in a warning letter related to its continuous glucose monitor (CGM ...
MedTech Dive

Abbott receives FDA warning letter over Freestyle Libre CGMs

Abbott needs to conduct more performance testing to ensure its FreeStyle Libre devices are accurate, FDA inspectors found.

Abbott Faces FDA Scrutiny On FreeStyle Libre And Broader Quality Story

Abbott Laboratories (NYSE:ABT) received an FDA warning letter focused on the accuracy and testing of its FreeStyle Libre ...
Nasdaq

Abbott Says Data Show FreeStyle Libre 3 System Most Accurate 14-Day Continuous Glucose Monitor

(RTTNews) - Abbott (ABT) said late-breaking clinical data showed the FreeStyle Libre 3 system has an overall mean absolute relative difference (MARD) of 7.9%, making it the first and only 14-day ...
Nasdaq

Abbott's FreeStyle Libre® 3 Receives U.S. FDA Clearance - Features World's Smallest, Thinnest and Most Accurate 14-Day Glucose Sensor

The FreeStyle Libre 3 system is the most accurate 14-day continuous glucose monitor1, with readings sent directly to a smartphone every minute.2 Designed for access and affordability, the FreeStyle ...
Drug Delivery Business

Abbott receives FDA warning letter related to FreeStyle Libre CGMs

Abbott (NYSE:ABT) is facing an FDA warning letter alleging quality system regulation violations related to FreeStyle Libre ...