Alphabet's life sciences research arm Verily received FDA 510(k) clearance for its Study Watch to offer an irregular pulse monitor feature.
Verily plans to leverage this new capability to detect irregular heart rate to build solutions to help with screening, diagnosis, and management of patients with atrial fibrillation, the most prevalent irregular heartbeat, William Marks, M.D., head of clinical science at Verily, wrote in a blog post.
"This validates our approach at Verily to building robust, clinical-grade tools and solutions that can support clinicians in delivering the highest level of care and improve self-management for patients," Marks wrote.
A year ago, Verily's clinical wearable—which is not available to consumers—received clearance from the U.S. Food and Drug Administration (FDA) as a Class II medical device for its on-demand electrocardiogram feature.
Verily has been working to research how best to gather health data on a wearable device. The company unveiled the Study Watch in April 2017 and positioned it as a clinical research tool.
Verily has been using it in a number of its own clinical research programs to collect biometric health information, including Project Baseline and the University of North Carolina and Harvard-led Aurora study.
Big pharmaceutical companies Novartis, Otsuka, Pfizer and Sanofi have also committed to using Verily's clinical wearable and broader Project Baseline platform.
In September, Verily announced a partnership with wearable ECG maker iRhythm Technologies to work on developing ways to better screen, diagnose and manage patients living with so-called “silent” afib, FierceBiotech reported.
IRhythm estimates that, of the patients who suffer a stroke due to afib, about 1 in 5 were previously unaware of their heart rhythm disorder. The company says more than 10 million people in the U.S. may be at high risk for the condition, with about one-third going undiagnosed.
Verily said it plans to explore opportunities to leverage Study Watch as a measure of irregular pulse in clinical settings across its cardiovascular programs, including its collaboration with iRhythm.
As part of that collaboration, iRhythm contributes its wearable biosensor devices as well as its experience in artificial intelligence-based arrhythmia diagnosis alongside Verily's data analytics expertise.
"Cardiovascular research and care has long been an area of focus for Verily, as millions of patients are impacted by cardiovascular conditions in the US on a daily basis," Marks wrote in the blog post. "Our objective is clear: work together to develop best-in-class solutions for improved screening, diagnosis, and management of patients with AFib."
In the post, Marks said research will continue to be an important part of developing the right features for devices to inform better care and ultimately prevent disease.
"Through research, we have been able to hone Study Watch to better capture rich signals from the human body and generate evidence to support various disease management, treatments, and interventions," he said.
Smartwatches and devices that track heart health are a growing trend. The Apple Watch received FDA clearance in 2018 for its ECG feature, officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms.
Wearables giant Fitbit, which Google plans to acquire, also plans to submit afib detection software to the FDA for regulatory review and approval, the company said in October.