It's been a long road, but the long-standing collaboration between iRhythm and Verily, the medical sciences-focused sister company of Google, has finally arrived at its goal: The FDA has given its approval for the pair's smartwatch and software that detects an irregular heartbeat.
Verily received agency approval for its ECG-equipped Study Watch, a prescription-only wearable made to monitor participants in clinical studies, for the first time in 2019. The following year, the Alphabet division added an FDA clearance for identifying atrial fibrillation symptoms, as part of an ongoing partnership with the leader in digital heart monitoring, iRhythm, reports FierceBiotech.
The new Zio Watch, which shares the branding of iRhythm's patch-like Zio devices that cling to the chest to detect cardiac signals, is the result of the evolution of that project, according to a blog post by Verily.
While iRhythm received FDA approval for the Zio Watch's artificial intelligence-powered AFib software, called Zeus, Verily received new FDA permission for the Zio Watch itself. That nod includes a computerized arrhythmia reporting service as well as the system's algorithms. 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), an 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 a 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 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.”