Dive Brief:
- The Food and Drug Administration cleared prior design modifications for iRhythm Technologies’ Zio AT wearable cardiac monitoring system in the first of two 510(k) submissions to the agency tied to ongoing remediation efforts.
- Last year, the FDA issued a warning letter to iRhythm after finding issues during an inspection that included failing to seek clearance before making changes to the system and marketing it for a new, high-risk patient population. Zio AT remains available on the U.S. market.
- CEO Quentin Blackford said in the Monday announcement that iRhythm submitted two 510(k) filings at the beginning of the year and anticipates hearing about the second in “the near future.”
Dive Insight:
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 is reported to the patient’s healthcare team to help physicians diagnose arrhythmias.
According to the FDA’s May 2023 warning letter, iRhythm began marketing Zio AT as a mobile cardiac telemetry monitor intended for “near real-time monitoring” of high-risk patients. The changes required new 510(k) submissions.
In its announcement, iRhythm said Zio AT and the Zio ECG Utilization Software enable ambulatory mobile cardiac telemetry monitoring service for non-critical care patients.
“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,” Blackford said.
Wall Street analysts welcomed the update. BTIG analyst Marie Thibault, in a research note, wrote the announcement “helps partially lift some of the regulatory overhang on the company.”
Citi Research analyst Joanne Wuensch, in a report to clients, said the changes to the device are minor modifications such as a new cellular chip to improve battery life that now have formal post-approval 510(k) clearance.