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, Oct. 21, 2024 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health care company focused on creating trusted solutions that detect, predict, and ...
The Zio AT wireless patch device is cleared by the FDA for continuous monitoring of heart rhythms in non-critical care patients during daily activities, where real-time monitoring is not needed. Data ...
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 ...
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 ...