iRhythm Technologies has received the US Food and Drug Administration (FDA) 510(k) approval for the ZEUS (Zio ECG utilisation software) system for the Zio Watch.
The US-based digital healthcare company created the new ECG utilisation software in partnership with Verily, a precision health company of Alphabet.
Both companies developed ZEUS System to combine deep learned algorithms with advanced cardiac arrhythmia service.
The system forms the AI algorithm and solution component of the Zio Watch, a sensor-based wearable for non-invasive continuous monitoring for atrial fibrillation (AFib).
Furthermore, Verily secured FDA 510(k) approval for the Zio Watch as a study watch with an irregular pulse monitor.
iRhythm CEO and president Quentin Blackford said: “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.
“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.”
Together with the Zio Watch, ZEUS System is an integrated, prescription-based solution that enhances clinician workflows, care pathways and the patient experience.
The Zio Watch is a wearable solution that not only detects AFib, but also determines the amount of AFib over time, supporting the clinicians in diagnosis.
It leverages uses a continuous photoplethysmography (PPG), AI-based algorithm to detect AFib and calculate an AFib burden estimate.
The device then sends a preliminary report to the clinician for review, facilitating diagnosis and clinical intervention.
Verily co-founder and chief medical and scientific officer Jessica Mega said: “Our partnership with iRhythm advances our shared mission of delivering more efficient care for patients with AFib.
“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.”
iRhythm noted that its Zio Watch and ZEUS System are not yet commercialised. The firm plans to roll out the ZEUS System for a limited market evaluation in 2023.
