iRhythm Technologies Received FDA 510(k) Clearance for Design Updates Previously Made to Its Zio® AT Device
On October 21, 2024, iRhythm Technologies, Inc., a leading digital healthcare company specializing in solutions to detect, predict, and prevent disease, announced that the U.S. Food and Drug Administration (FDA) granted clearance for its 510(k) submission addressing previous design changes made to the Zio AT device through a letter to file. The Zio AT device remained available on the market and continued to be shipped to customers across the United States.
“This clearance is related to modifications and certain enhancements to our Zio AT device prev...
