iRhythm Technologies (Nasdaq:IRTC) announced today that it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system.
ZEUS, produced in partnership with Google’s Verily, combines deep-learned algorithms with iRhythm’s trusted cardiac arrhythmia service, providing the AI algorithm and solution component for the Zio Watch sensor-based wearable for non-invasive, clinical-grade, long-term continuous monitoring for AFib.
According to a news release, Verily also received FDA 510(k) clearance for the Zio Watch (study watch with irregular pulse monitor).
San Francisco-based iRhythm said that ZEUS provides an integrated, prescription-based solution that addresses clinician workflows, care pathways and the patient experience, while the wrist-worn Zio Watch not only detects AFib but also characterizes the amount of AFib over time.
Zio Watch uses a continuous photoplethysmography (PPG), AI-based algorithm to detect AFib and …