Google’s sister company Verily and iRhythm Technologies have received 510(k) clearance from the Food and Drug Administration for a new AI-powered smartwatch system to monitor cardiac arrhythmia, iRhythm said in a statement released on Friday.
The approval covers both the Zio Watch, a new smartwatch developed by Verily and iRhythm, and the Zio ECG Utilization Software System, called Zeus, an artificial intelligence algorithm that monitors cardiac arrhythmia. The two companies are working together to develop the watch for long-term continuous monitoring for atrial fibrillation (AFib).
The combined device detects and characterizes the amount of AFib a patient has over time, helping clinicians in diagnosis. After data is collected with the Zio Watch and analyzed, a report is sent to the patient’s clinician for review.
The Zio Watch and Zeus system are not yet commercially available.
iRhythm, a cardiac monitor maker, and Verily began a partnership in 2019 to improve the screening, diagnosing and management of patients with AFib, building on iRhythm’s portfolio of wearable cardiac monitors.
The Zio Watch will have to catch up with the Apple Watch, which is cleared for multiple heart monitoring services and is already on the market. The most recent clearance came in June and allows patients to track how frequently their heart rhythm shows signs of AFib. The Apple Watch was cleared for use in the detection of irregular heart rhythms in 2018.
Daniel Wilson, iRhythm’s executive vice president of strategy, corporate development and investor relations, said during a May earnings call that if the Zio Watch is cleared in 2022, the company will then begin market evaluation in early 2023.
William Blair analysts wrote in a May report that the Zio Watch can stand out in the wearables market because of iRhythm’s artificial intelligence capabilities, which the company already uses in its Holter monitors.
