The FDA granted Verily an additional 510(k) clearance for its Study Watch with the Irregular Pulse Monitor. The company will offer Study Watch as a measure of irregular pulse in clinical settings.
The Study Watch with Irregular Pulse Monitor is indicated for use by adult patients who have been diagnosed with, or are susceptible to developing, atrial fibrillation. The Irregular Pulse Monitor is indicated for use in professional healthcare facility environments, while worn as a wristwatch.
Study Watch will not be directly available to consumers, the company said. Verily, a subsidiary of Google parent company Alphabet, is collaborating with iRhythm to support continuous monitoring, data-analytics and cloud-based machine learning to monitor atrial fibrillation.