iRhythm Receives FDA Clearance for its ZEUS System

FDA 510k clearance for ZEUS (Zio ECG Utilization Software) System for Zio Watch has been received.

Image: Verily

Today iRhythm Technologies, a leading digital healthcare solutions company focused on the advancement of cardiac care, announced it received FDA 510(k) clearance for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch. Produced in partnership with Verily, an Alphabet precision health company, the ZEUS System combines deep learning algorithms with a proven and trusted cardiac arrhythmia service. The ZEUS System is the AI algorithm and solution component of the Zio® Watch: a sensor-based wearable for the noninvasive, clinical grade, long-term continuous monitoring of atrial fibrillation (AFib). Verily also received FDA 510(k) clearance for the Zio Watch (Study Watch with Irregular Pulse Monitor).

Read more: Fitbit Gets US FDA Approval For Detecting AFib

The Zio Watch with the ZEUS System is an integrated, prescription-based solution that addresses clinician workflows, care pathways, and the patient experience. The cleared Zio Watch is a wrist-worn solution that not only detects AFib, but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. The Zio Watch uses a continuous photoplethysmography (PPG), an AI-based algorithm to detect AFib and calculate an AFib burden estimate. A preliminary report is then sent to the patient's clinician for review, potentially leading to a diagnosis and clinical interventions, according to a press release.

“We are incredibly excited about this important milestone as we make progress in bringing a new monitoring platform to patients who can benefit from it. 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. “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.”

“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 Co-founder 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 intervention that could ultimately prevent more serious cardiac events before they can occur.”

iRhythm has what is believed to be the world’s largest repository of labeled ECG data, which it leveraged to develop its proprietary PPG algorithm. Findings from the Verily Study: Watch AFib Detection At Home, revealed at HRS, 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. Zio XT was used as a reference for computing performance. AFib episodes occurred in 30.4% of subjects, and the median AFib burden was 9.3%. The Zio Watch PPG-derived AFib burden estimate was an accurate measure when compared to the Zio XT reference. iRhythm's proprietary ACE algorithm utilizes a novel convolutional neural network architecture designed to operate on a cloud-enabled system compatible with a battery-constrained device. The results of ACE are presented in clinical preliminary reports summarizing AFib presence over the monitoring period. This process enables clinicians to receive clinically meaningful data on AFib presence/absence, rather than just a single data point in time.

“We’re proud to introduce a clinical-grade wearable that has the potential to fill an important gap in patient care by enabling the early detection and long-term monitoring of atrial fibrillation,” said Mark Day, Chief Technology Officer at iRhythm. “This technology is fundamental to growing a disruptive new monitoring platform for iRhythm.”

The Zio Watch will be complementary to Zio monitors by adding a modality with longer wear times for patients who require long-term monitoring in order to detect, characterize, and manage AFib. The Zio Watch is designed to be a cost-effective, noninvasive monitoring solution, and will fully integrate with the Zio service. iRhythm plans to introduce the ZEUS System for a limited market evaluation in 2023.

Disclaimer: The Zio Watch and the ZEUS System are not yet commercially available at this time and iRhythm will continue to build clinical research going into 2023.

About iRhythm Technologies, Inc.

iRhythm is a leading digital healthcare company redefining the way cardiac arrhythmias are clinically diagnosed. The company combines wearable biosensor devices worn for up to 14 days and cloud-based data analytics with powerful proprietary algorithms that distill data from millions of heartbeats into clinically actionable information. The company believes improvements in arrhythmia detection and characterization have the potential to change the clinical management of patients.

About Verily

Verily is a subsidiary of Alphabet that is using a data-driven, people-first approach to change the way people manage their health and the way healthcare is delivered. Launched from Google X in 2015, Verily’s purpose is to bring the promise of precision health to everyone - every day. Verily is focused on generating and activating data from a wide variety of sources, including clinical, social, behavioral, and the real world, to arrive at the best solutions for a person based on a comprehensive view of the evidence. Verily uses its recognized expertise and capabilities in technology, data science, and healthcare to enable the entire healthcare ecosystem to drive better health outcomes.

Jürgen Thalmayer
August 30, 2022

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