Business
iRhythm Gains FDA Clearance for its Clinically Integrated ZEUS System
Developed in partnership with Verily, the Zio® Watch and the ZEUS System combine to create a clinical grade watch to detect and characterize AFib and
About this update from Irhythm Holdings, Inc.
[{"type":"text","content":"Developed in partnership with Verily, the Zio® Watch and the ZEUS System combine to create a clinical grade watch to detect and characterize AFib and integrate with clinician’s workflow\nSAN FRANCISCO, July 22, 2022 (GLOBE NEWSWIRE) -- iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today announced it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learned algorithms with a proven and trusted cardiac arrhythmia service. The ZEUS System is the AI algorithm and solution component of the Zio® Watch: a sensor-based wearable for noninvasive, clinical grade, long-term continuous monitoring for atrial fibrillation (AFib). Verily also received FDA 510(k) clearance for the Zio Watch (Study Watch with Irregular Pulse Monitor). The Zio Watch with the ZEUS System is an integrated, prescription-based solution that addresses clinician workflows, care pathways and the patient experience. The cleared Zio Watch is a wrist-worn solution that not only detects AFib, but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. The Zio Watch uses a continuous photoplethysmography (PPG), AI-based algorithm to detect AFib and calculate an AFib burden estimate. A preliminary report is then 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,” said Quentin Blackford, CEO and President of iRhythm. “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,” said Dr. Jessica Mega, Chief Medical and Scientific Officer and Co-founder of Verily. “The industry is ripe for a clinical grade wearab...