FDA Approves Google’s Atrial Fibrillation Detection Device

The Food and Drug Administration has awarded 501k clearance to Verily and iRhythm Technologies for the new cardiac arrhythmia feature on their Zio Watch. The approval comes as wearables continue to become an integral part of healthcare treatment. Wearables can be used to contact others, for navigation, and perhaps most importantly, monitor a user’s health. Google has recognized the potential wearables have to help individuals and encouraged their sister company Verily and iRhythm Technologies to design a wearable capable of competing in the wearables market. 

The company created the Zio Watch. The new device works in collaboration with Zio ECG Utilization Software System (ZEUS), an AI-based algorithm that monitors arrhythmia in its users. Arrhythmia is an abnormality in the heart’s rhythm. The most effective way to detect arrhythmia is by using an electrocardiogram, which records an individual’s heart rhythm. The Zio Watch has been designed to monitor atrial fibrillation, a type of arrhythmia, over a long period of time. The data monitored can then be used by a clinician to diagnose a patient. 

In a statement released on July 22, Quentin Blackford, CEO and President of iRhythm said “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 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.”

The Zio Watch and Zeus system is set to be released in early 2023. The new device will seek to compete with the Apple Watch, whose atrial fibrillation device has also received FDA clearance. The Apple Watch was approved for detecting irregular heart rhythm in 2018. However, its most recent clearance regards its ability to track how frequently their heart rhythm demonstrates signs of atrial fibrillation for a long term period. Although the Apple Watch has entered the wearables market before the Zio Watch, experts believe the Zio Watch has the potential to outsell its competitor due to its artificial intelligence capabilities.