The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.
Medtronic plc teamed up with healthtech software company Modernizing Medicine Inc. (Modmed) to make colonoscopy procedures more efficient by integrating data generated from Medtronic’s GI Genius system into Modmed's Ggastro EHR software to enhance endoscopic care.
The U.S. FDA’s final rule for lab-developed tests was a long time in coming even if the agency shorted the public comment period for the draft rule, and the final rule makes several major concessions about circumstances in which the agency would exercise enforcement discretion.