Atrial fibrillation (AF), a common heart rhythm disorder, can lead to severe complications, including stroke and heart failure. Early detection and management are crucial for preventing these adverse events. Wearable technology has emerged as a promising tool for AF detection, but current consumer-grade devices fall short of clinical-grade standards. In a groundbreaking development, researchers have introduced a clinical-grade wristwatch that offers continuous monitoring of heart rhythm and employs an innovative algorithm for AF detection.
The Verily Study Watch: A Clinical-Grade Wearable
Developed by a team at the University of Michigan, the Verily Study Watch stands out as a clinical-grade device. It utilizes photoplethysmography (PPG) to continuously monitor heart rhythm changes and detect potential AF episodes. When AF is suspected, the device prompts the wearer to take a single-lead electrocardiogram (ECG) for confirmation. This ECG result is then reviewed by a cardiographic technician and communicated to the patient’s doctor, ensuring clinical-grade accuracy.
Addressing Skin Tone Bias and Maintaining Accuracy Across Activity Levels
The Verily Study Watch underwent rigorous testing, involving over 100 participants between September 2020 and May 2021. The device demonstrated impressive accuracy in identifying AF, comparable to existing PPG-based devices. While a slight dip in performance was observed for detecting AF in participants with darker skin tones, the device still successfully identified AF cases in these individuals.
Significantly, the study evaluated the device’s performance across all physical activity levels. The Verily Study Watch maintained its accuracy in detecting AF during both low and moderate physical activities, a significant advantage over many consumer-oriented wearables that struggle with motion artifacts.
Bridging the Gap Between Consumer Wearables and Clinical Decision-Making
Unlike consumer-grade devices like the Apple Watch and Fitbit, which are FDA-approved only for pre-diagnostic use, the Verily Study Watch has the potential to bridge the gap between consumer wearables and clinical decision-making. The FDA has granted 510(k) clearance to Verily, acknowledging the device’s efficacy and its comparability to other legally marketed medical devices.
Implications for Future AF Management
“Right now, we typically manage patients with atrial fibrillation using electrocardiogram, or ECG, patches that we put on the chest, but the future of Afib management will be on the wrist,” said Hamid Ghanbari, M.D., M.P.H., a cardiac electrophysiologist at the University of Michigan Health Frankel Cardiovascular Center.
The Verily Study Watch represents a significant step forward in AF detection and management. Its clinical-grade accuracy, continuous monitoring capabilities, and ability to provide confirmatory ECGs could revolutionize the way AF is diagnosed and managed. As research continues and the device undergoes further refinement, it has the potential to play a transformative role in improving patient outcomes.