On Monday, the FDA approved iRhythm Technologies, Inc.’s IRTC 510(k) submission related to prior design changes to the Zio AT device via letter to file.Zio AT remains commercially available to ship to customers in the United States.“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,” said Quentin Blackford, iRhythm President ...