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 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,” iRhythm CEO and President Quentin Blackford said in the release. “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.”
iRhythm said the Zio Watch will be complementary to Zio monitors by adding a modality with longer wear times for patients who require long-term monitoring for AFib. The company designed it to be a cost-effective, non-invasive monitoring option that will fully integrate with the Zio service. The company intends to introduce ZEUS through a limited market evaluation in 2023.
“Our partnership with iRhythm advances our shared mission of delivering more efficient care for patients with AFib,” 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 said that findings from the Verily Study: Watch AFib Detection At Home demonstrated that interval-level sensitivity and specificity of the AFib Context Engine (ACE) algorithm within the ZEUS System were 93.6% and 99.1%, respectively.
The Zio Watch and ZEUS system aren’t commercially available yet and the company plans to build further clinical research going into next year.
“We’re proud to introduce a clinical-grade wearable that has the potential to fill an important gap in patient care by enabling the early detection and long-term monitoring of atrial fibrillation,” iRhythm CTO Mark Day said. “This technology is fundamental to growing a disruptive new monitoring platform for iRhythm.”