The partnership between iRhythm and Google’s sister company Verily recently got a big boost; the Food and Drug Administration (FDA) has granted 510(k) clearance for the duo’s AI-powered system for monitoring cardiac arrhythmia. The pairing combines the ZEUS (“Zio ECG Utilization Software”) algorithm and the Zio Watch — both of which, it bears noting, are not yet commercially available. In a press statement, iRhythm says it plans to roll out a limited release in 2023.
So what can we expect when the fruits of the partnership hit the market? The Zio Watch is a sensor-based wearable that offers continuous clinical-grade monitoring of atrial fibrillation (AFib), which includes not just detecting AFib, but also gauging its amount over time — a tool aimed at helping clinicians with diagnoses. How? Using continuous optical measurements, an algorithm detects AFib and calculates the AFib burden estimate, which is determined by quantifiable factors, including the number of arrhythmias and their durations. This data the Zio Watch gathers is sent to a clinician for evaluation.
If the name Zio sounds familiar, it’s probably because you’ve heard of their monitors. Worn on the chest, the Zio patch is an ambulatory cardiac monitor that records heartbeats and serves as a tool for detecting irregularities. And soon, according to iRhythm, the Zio Watch will work in concert with Zio monitors to offer longer wear times and thus longer-term heart monitoring.
This recent blessing from the FDA has been a long time coming; Verily and iRhythm first paired up back in 2019, with iRhythm giving Verily $5 million to kick off the development of new AFib technologies, pledging nearly $13 million more in milestones down the road. It was big money that targeted a big market; according to the Cleveland Clinic, more than 6 million Americans have AFib, with an expected rise to over 12 million by the year 2030. Contributing to the overall increase, AFib is common among people with severe COVID-19, according to findings from the National Institutes of Health.
Regarding the recent FDA clearance, iRhythm CEO Quentin Blackford says, “There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution…iRhythm is focused on redefining the standard of care with earlier insight to predict and prevent disease, and the Zio Watch with [the] ZEUS System provides clinicians a platform that has the potential to meaningfully improve patients’ lives.”