iRhythm Technologies Receives 510(k) Clearance for Zio Watch Software

San Francisco, Calif.-based iRhythm Technologies has received 510(k) clearance from the FDA for its Zio ECG Utilization Software (ZEUS) for the Zio Watch.

The software, which uses proprietary algorithms to provide noninvasive long-term monitoring for atrial fibrillation, was developed in partnership with Verily, an Alphabet company, as part of a collaboration deal inked in September 2019. Verily previously received 510(k) clearance for the Zio Watch.

The prescription-only Zio Watch and ZUES system sends a report to the patient’s clinician for review, potentially leading to a diagnosis and clinical intervention.

The companies plan to continue research into 2023 before releasing the Zio Watch and its affiliated software.