iRhythm: FDA clears design updates previously made to Zio AT device

iRhythm (IRTC) Technologies announced that the U.S. Food and Drug Administration FDA has granted clearance for its 510(k) submission related to prior design changes made to the Zio AT device via letter to file. Zio AT remains commercially available on the market to ship to customers in the United States. “This clearance is related to modifications and certain enhancements to our Zio AT device previously made via letter to file and has been a priority for our teams to demonstrate iRhythm’s commitment to quality, compliance and performance,” said Quentin Blackford, iRhythm President and Chief Executive Officer. “We are pleased to have received this first 510(k) clearance in line with the sequence of how we submitted the first of two 510(k)s at the beginning of this year, and we look forward to hearing about our second 510(k) in the near future. Both 510(k) submissions are related to our ongoing remediation efforts with the FDA, and we remain committed to patient safety, physician trust in Zio AT’s clinical performance, service quality, and regulatory compliance.”