FDA Sends Warning Letter to iRhythm over Zio AT Telemetry Device Violations
San Francisco, California – The U.S. Food and Drug Administration (FDA) recently issued a warning letter to iRhythm Technologies over violations related to its Zio AT mobile cardiac telemetry device. The letter, published on the FDA’s website, outlined various concerns, including the company’s failure to report patient deaths and other violations within the required timeframe. … Read more