It's been a long journey, but iRhythm’s long-running partnership with Google’s life science-focused sister company Verily has finally reached its destination: The FDA handed down its blessing for the pair’s smartwatch and software used to detect an irregular heartbeat.
Verily first won an agency clearance for its ECG-equipped Study Watch in 2019, as a prescription-only wearable designed to help keep tabs on participants in clinical studies. The next year, the Alphabet division added an FDA green light for detecting signs of atrial fibrillation, amid an ongoing collaboration with the digital heart monitoring maven iRhythm.
Now, that project has evolved into the new Zio Watch, Verily said in a company blog post, sharing the branding of iRhythm’s patch-like Zio devices that stick to the chest to track cardiac signals.
While Verily scored a new FDA clearance for the Zio Watch itself, iRhythm won its own agency OK for the device’s artificial intelligence-powered AFib software, dubbed Zeus. That nod covers the system’s algorithms as well as a digital arrhythmia reporting service.
iRhythm said it plans to start rolling out the Zeus system within a limited number of clinical trials in 2023, while continuing its own studies of the device itself through the remainder of this year. For now, the watch will only be available in clinical studies, with a prescription.
According to iRhythm, Zeus is designed to not only spot signs of AFib, but characterize their seriousness over time to help aid diagnosis. Using the watch’s light-based pulse sensors, the software calculates an AFib burden estimate and delivers a report to the patient’s clinician for review.
Verily, meanwhile, said the main upgrade of the Zio Watch over its heart-focused predecessors is its ability to integrate with healthcare providers through a cloud-based data network. With its week-long battery life and comparatively fewer features, the watch aims to operate in a class separate from consumer-grade heart-tracking wearables such as Fitbit devices and the Apple Watch.
“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,” Verily’s chief medical and scientific officer, Jessica Mega, said in a press release.
In a study comparing the latest smartwatch’s AFib accuracy with the chest-worn Zio XT patch, the Zeus system delivered a false-negative rate of 6.4%, and a false-positive rate of less than 1%, iRhythm said.
Verily has been working to expand use of its prescription-only watch since its debut. But last year, the FDA rejected the company’s application to add software for cataloging physical symptoms of Parkinson’s disease using its motion trackers.
The system had prompted users to complete a series of tasks once per week, including tapping the smartwatch, opening and closing the hand, stomping a foot and standing still. However, the FDA said such unsupervised measures were unlikely to be directly linked to the disease's effects on everyday life, compared to the patient’s ability to speak, eat and dress themselves.