The Food and Drug Administration cleared prior design modifications for iRhythm Technologies’ Zio AT wearable cardiac monitoring system in the first of two 510(k) submissions to the agency tied ...
Quentin Blackford, President and CEO of iRhythm, stated, "This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a ...
iRhythm's stock surged over 20% today after the FDA cleared its 510(k) submission for the Zio AT device, despite ongoing regulatory challenges. The company still faces significant hurdles ...
iRhythm Technologies, Inc. IRTC has received FDA 510(k) clearance for design changes and enhancements previously made to its Zio AT device. These modifications, submitted via letter to file ...
SAN FRANCISCO - iRhythm Technologies, Inc. (NASDAQ:IRTC), a company specializing in digital healthcare solutions, announced today that it has received clearance from the U.S. Food and Drug ...