FDA OKs iRhythm’s ZEUS System for the Zio Watch

iRhythm Technologies has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its ZEUS (Zio ECG Utilization Software) system for the Zio Watch.
 
Produced via partnership with Verily, the ZEUS system combines deep learned algorithms with a cardiac arrhythmia service. It’s the AI algorithm and solution component of the Zio Watch—a sensor-based wearable for noninvasive, long-term continuous monitoring for AFib.
 
The wrist-worn device also characterizes the amount of AFib over time to aid diagnosis. It uses a continuous photoplethysmography (PPG), AI-based algorithm to spot AFib and calculate an AFib burden estimate. A preliminary report is sent to the patient’s clinician for review, potentially leading to diagnosis and clinical intervention.
 
“We are incredibly excited about this important milestone as we make progress in bringing a new monitoring platform to patients who can benefit from it. There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution,” Quentin Blackford, CEO and president of iRhythm told the press. “iRhythm is focused on redefining the standard of care with earlier insight to predict and prevent disease, and the Zio Watch with ZEUS System provides clinicians a platform that has the potential to meaningfully improve patients’ lives.”
 
“Our partnership with iRhythm advances our shared mission of delivering more efficient care for patients with AFib,” added Dr. Jessica Mega, chief medical and scientific officer and co-founder of Verily. “The industry is ripe for a clinical grade wearable to not only improve how we monitor cardiovascular health, but also develop precision health interventions that could ultimately prevent more serious cardiac events before they can occur.”
 
iRhythm plans to introduce the ZEUS System for a limited market evaluation in 2023.