AI algorithm, pulse monitoring watch system gains FDA clearance
iRhythm Technologies announced it received FDA 510(k) clearance for its artificial intelligence atrial fibrillation monitoring algorithm for use with Verily’s irregular pulse monitoring watch.
Verily also received FDA 510(k) clearance for its pulse monitoring watch (Zio Watch).
According to a company press release, the AI algorithm (ZEUS) was developed in partnership by the two companies.
The combined AI algorithm and monitoring watch system is prescription-based solution to detect AF and characterizes the amount of AF over time and aiding a clinician in diagnosis.
The combined solution uses a continuous photoplethysmography algorithm to detect AF and calculate AF burden, and subsequently sends a preliminary report to the wearer’s clinician for review, according to the release.
The results from the Verily Study which tested the present combination system to detect AF indicated that the interval-level sensitivity and specificity of the AI algorithm were 93.6% and 99.1%, respectively, according to the release.
“There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution,” Quentin Blackford, CEO and president of iRhythm, said in the release.
“Our partnership with iRhythm advances our shared mission of delivering more efficient care for patients with AFib,” Jessica Mega, MD, MPH, chief medical officer, chief scientific officer and co-founder of Verily, said in the release. “The industry is ripe for a clinical grade wearable to not only improve how we monitor cardiovascular health, but also develop precision health interventions that could ultimately prevent more serious cardiac events before they can occur.”
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