iRhythm and Verily Receive FDA Clearance for Zio Watch to Detect AFib

Author: Fran Kritz

Topics: 

• Medical Device Industry
• Mobile Health

iRhythm Technologies and Verily, an Alphabet company (the parent company of Google), have received 510(k) premarket clearance from the FDA for an AI-powered smartwatch system to monitor atrial fibrillation or AFib. The system, called ZEUS (Zio ECG Utilization Software), is utilized on the company’s Zio Watch, a wrist-worn wearable, that according to the company detects AFib and also characterizes the amount of AFib over time, which can be a diagnosis aid for physicians.

“There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution,” said Quentin Blackford, CEO and President of iRhythm, in a press release. “iRhythm is focused on redefining the standard of care with earlier insight to predict and prevent disease, and the Zio Watch with ZEUS System provides clinicians a platform that has the potential to meaningfully improve patients’ lives.”

According to iRhythm, findings from the Verily Study: Watch AFib Detection At Home, show that interval-level sensitivity and specificity of the AFib Context Engine (ACE) algorithm within the ZEUS System were 93.6% and 99.1% respectively. “iRhythm's proprietary ACE algorithm uses a novel convolutional neural network architecture designed to operate on a cloud-enabled system compatible with a battery-constrained device, and the system allows physicians to receive clinically meaningful data on AFib’s presence or absence rather than just a single data point in time,” according to the companies.

“Our partnership with iRhythm advances our shared mission of delivering more efficient care for patients with AFib,” said Dr. Jessica Mega, Chief Medical and Scientific Officer and cofounder of Verily. “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.”

The companies hope to launch the Zio Watch and Zeus System during 2023. In June, Apple received 510(k) clearance from the FDA for a new feature for its smartwatch that estimate how often a wearer’s heart rhythm shows signs of AFib.