iRhythm Technologies, a digital healthcare solutions company focused on cardiac care advancements, announced FDA clearance of its ZEUS (Zio ECG Utilization Software) System for the Zio Watch.

“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,” said Quentin Blackford, CEO and president of iRhythm. “There is a clear need in the market today for a clinical grade, long-term and noninvasive monitoring solution. 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.”

The Zio Watch is a sensor-based wearable for noninvasive, cost-effective, clinical grade, long-term continuous monitoring for atrial fibrillation (AFib). The ZEUS System is the artificial intelligence (AI) algorithm and solution component of the watch. Created in partnership with Verily, an alphabet precision company, the ZEUS System combines deep learned algorithms with the proven and trusted Zio Watch to detect AFib and characterize the amount of AFib over time, which can help in diagnosis.

The watch uses continuous photoplethysmography (PPG), and AI-based algorithm to detect and calculate an AFib burden estimate. After the Zio watch is taken off, a preliminary report is sent to the patients clinician for review. The report is created using the company’s ACE algorithm which utilizes a convolutional neural network architecture that operates on a cloud-enabled system. This system is compatible with a battery-constrained device. The ACE results summarize the presence of AFib over the monitoring period, enabling clinicians to see data on AFib presence or absence instead of only a single data point at a time. This could potentially lead to meaningful diagnosis and clinical intervention.

“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,” said Jessica Mega, MD, chief medical and scientific officer and co-founder of Verily.

Additionally, the company, according to the press release, has the world’s largest repository of labelled ECG data. Using this wealth of the data, findings from a Verily study revealed that “interval-level sensitivity and specificity of the AFib Context Engine (ACE) algorithm within the ZEUS System were 93.6% and 99.1% respectively. AFib episodes occurred in 30.4% of subjects, and median AFib burden was 9.3%.”

The study showed that the Zio Watches PPG-derived AFib burden estimate was accurate when compared to the Zio XT reference. The prescription-based system, according to the iRhythm, addresses clinician workflows, care pathways, and patient experience.

iRhythm said it intends to introduce the ZEUS System for a limited market evaluation in 2023.

“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.”