One year after receiving its first FDA clearance bringing electrocardiogram capabilities to its prescription-only smartwatch designed for clinical studies, Verily has obtained a second agency green light for measuring irregular heartbeats.
The life sciences-focused Alphabet company plans to use the watch across its cardiovascular programs, according to Verily’s head of clinical science, William Marks, M.D. This includes the company’s collaboration with cardiac monitoring firm iRhythm, which employs its Zio service for cloud-based data gathering and analytics for atrial fibrillation.
“Cardiovascular research and care has long been an area of focus for Verily, as millions of patients are impacted by cardiovascular conditions in the U.S. on a daily basis,” Marks wrote in a company blog post. “iRhythm’s own research estimates that 10 million Americans are at high risk for atrial fibrillation—the most prevalent irregular heartbeat that can lead to blood clots and stroke. Our objective is clear: work together to develop best-in-class solutions for improved screening, diagnosis and management of patients with AFib.”
Verily and iRhythm’s joint project was first announced last September, with the goal of detecting so-called “silent” cases of afib. IRhythm estimates that about 20% of people who have suffered a stroke were previously unaware of their irregular heartbeat, which is also associated with other risk factors including high blood pressure, diabetes and sleep apnea.
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Since then, the two companies have worked to integrate their respective tools, with the aim of building a full clinical workflow solution, Marks said. In addition, Verily is continuing to use its Study Watch to collect health information from participants in its research studies, including Project Baseline.
The latest 510(k) clearance for the device’s irregular pulse monitor is indicated for adult patients age 22 and older who have “been diagnosed with, or are susceptible to developing, atrial fibrillation,” according to Verily. It is intended for use within professional healthcare facilities and will not be made available to consumers.