Verily’s clinical-grade smartwatch, empowered by real-world evidence, revolutionizes atrial fibrillation monitoring

A new clinical-grade smartwatch developed by Verily Life Sciences leverages real-world data (RWD) for highly accurate atrial fibrillation detection through continuous monitoring, marking a significant stride in wearable technology for personalized health care.

The recent proliferation of consumer-grade smartwatches has led to an increase in false alarms for irregular heartbeats, posing a challenge for healthcare providers. “Unfortunately, this has led to a tsunami of healthy patients coming to clinics complaining about having atrial fibrillation, and we see many false positives without really having a way to use these devices clinically,” said Dr Hamid Ghanbari, a cardiac electrophysiologist at the University of Michigan Health Frankel Cardiovascular Center.

To address this clinical gap, a research team led by Ghanbari has developed the Verily Study Watch: the first diagnostic wrist-worn device specifically designed for long-term atrial fibrillation surveillance. This clinical-grade smartwatch utilizes a unique algorithm trained on RWD from over 100 participants to continuously monitor the wearer’s heart rhythm and accurately detect atrial fibrillation.

Unlike traditional methods that use chest-mounted electrocardiogram (ECG) patches, the Verily Study Watch allows for real-time monitoring on the wrist. Employing photoplethysmography, the watch sends light pulses through the skin into blood vessels to detect subtle changes in heart rhythm. If atrial fibrillation is suspected, the wearer is prompted to take a single-lead ECG for confirmation. The results are then analyzed by a cardiographic technician before being shared with the participant’s physician.

The clinical study published in the Journal of the American Heart Association confirmed the Verily Study Watch’s ability to accurately detect atrial fibrillation episodes. Between September 2020 and May 2021, the device’s deep neural network algorithm analyzed data from over 100 participants every 15 minutes, demonstrating comparable performance to other atrial fibrillation-detecting smartwatches using photoplethysmography technology. Notably, the study was the first to assess the algorithm’s performance across various levels of physical activity.

While the device exhibited a slight decrease in performance for participants with darker skin tones during some episodes of atrial fibrillation, it was still successful in detecting irregular heart rhythms in these patients. The smartwatch has received 510(k) clearance from the FDA, a premarket submission to demonstrate efficacy and similarity to a legally marketed device.

Ghanbari noted, “there is a need for clinical grade wrist-worn wearable that is affordable and can be prescribed by clinicians for the long term, personalized and continuous management of patients with atrial fibrillation.” The Verily Study Watch could be this crucial link, allowing healthcare providers to effectively utilize wearable data for managing patients with atrial fibrillation. Equipped with a sophisticated algorithm trained on RWD, the device offers a practical solution for atrial fibrillation detection and burden assessment, providing clinicians with a powerful tool to enhance patient care.