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Alphabet's Verily unit announced that its Study Watch with irregular pulse monitor has received FDA 510(k) clearance for use by adults aged 22 years and older who have been diagnosed with, or are susceptible to developing, atrial fibrillation (AF). William Marks, head of clinical science at Verily, said "this new indication will explore opportunities to leverage Study Watch as a measure of irregular pulse in clinical settings across our cardiovascular programmes, including our collaboration with iRhythm."
Verily introduced the investigational device in 2017 as a way of passively capturing a person's health data for use in medical research studies. Last year, the Study Watch's on-demand electrocardiography (ECG) feature received FDA 510(k) clearance as a Class II medical device.
Marks noted that since announcing the collaboration with iRhythm last September, "our product and engineering teams have begun work on technical integrations and exploring how we can leverage tools like Study Watch with ECG and irregular pulse monitor and iRhythm's Zio service to support continuous monitoring, data analytics and cloud-based machine learning to monitor AF." He added that, while still in the early stages, "we aim to create a clinical solution that takes into account clinician workflows, care pathways and the patient experience."
Verily is also continuing to use Study Watch to collect biometric health information through its clinical research programmes, including Project Baseline, which was launched in 2017 to gather broad phenotypic health data from around 10,000 participants over four years of follow-up.
For related analysis, see The Wider View: Alphabet's ex-Commish hire could help piece together digital healthcare puzzle faster.
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