Home Technology FDA Awards 510(k) Clearances for ZEUS System/Zio Watch

FDA Awards 510(k) Clearances for ZEUS System/Zio Watch

45
0


iRhythm + Verily Awarded FDA Clearances on ZEUS System/Zio Watch

What You Should Know:

– Today, iRhythm (a digital health company) and Verily (Alphabet’s life sciences research organization) announced joint FDA 510(k) clearances for the ZEUS System and Zio Watch. Together they create an integrated, prescription-based solution that will improve clinician workflows, care pathways and the patient experience. 

– The ZEUS System is the AI algorithm and solution component of the Zio Watch – a clinical grade, long-term and noninvasive wearable that not only detects atrial fibrillation (AFib) but also characterizes the amount of AFib over time, thus aiding a clinician in diagnosis. iRhythm has what is believed to be the world’s largest repository of ECG data, which is leveraged to develop its proprietary PPG algorithm.

Integrated, Prescription-Based Solution

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 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 intervention.

“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.”

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, non-invasive monitoring solution and will fully integrate with the Zio service. iRhythm plans to introduce the ZEUS System for a limited market evaluation in 2023.

Previous articleRecent COVID Doesn’t Seem to Raise Surgery Risks
Next articleMonday Morning Update 7/25/22 – HIStalk