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 has announced that the US Food and Drug Administration (FDA) has cleared design updates made to its Zio AT device. The Zio AI continuous monitoring system combines a wearable ...
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 ...
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 ...
SAN FRANCISCO - iRhythm Technologies, Inc. (NASDAQ:IRTC), a digital healthcare company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Zio AT device for upcoming ...