Friday, Food and Drug Administration grant another 510(k) clearance to iRhythm Technology Its artificial intelligence-driven software system is designed to work with realof irregular pulse tracking watch.
The ZEUS (Zio ECG Utilization Software) system is trained to monitor atrial fibrillation (AFib) and is licensed under several licenses. FDA’s websiteThe latest clearance is for an algorithm that classifies patients’ AFib by analyzing how much they experience over time.
iRhythm Technologies is a San Francisco-based cardiac arrhythmia diagnostics company. listed In a $107 million IPO in 2016.For the past two years, it has been working with Verily to develop the ZEUS system with Verily’s watches, which are Also FDA approved. The goal of the cooperation is to According to iRhythm CTO Mark Day, create an AFib monitoring wearable that clinicians take seriously, not like consumer technology.
Verily’s watch is a prescribed medical device for long-term non-invasive, continuous monitoring of AFib. The wearable device is based on photoplethysmography (PPG), which uses a light source and photodetectors on the patient’s skin to measure volume changes in the blood circulation. A recently FDA-approved algorithm uses the test to describe the amount of AFib that occurs over time — a metric iRhythm calls “AFib burden.”
The ZEUS system sends an estimate of a patient’s AFib burden directly to their physician for interpretation and treatment management, with the goal of helping patients receive more timely and appropriate treatment. iRhythm trained the algorithm on what it believes to be the largest repository of labeled ECG data ever, spanning over a billion hours.
“It’s not just raw ECG data, it’s curated ECG data,” Dai noted. “This is our core business now: curating the ECG, labeling it, and interpreting the exact time period that triggers the ECG AFib.”
To date, the fact that the system sends information directly to doctors rather than patients is key.This is what differentiates the ZEUS system and Verily watches from other AFib detection wearables such as Apple WatchHe says.
“We not only provide the information, but we also provide it directly to the attending physician,” Day declared. “It’s the opposite of giving it to consumers, who have to figure out how to give this information to doctors.”
Despite FDA approval, neither Verily’s watch nor the ZEUS system are on the market.
Day said the system has been validated in a 120-patient trial that collected data from people 65 and older in an outpatient setting. More such trials are underway at iRhythm, he said, and the company is now more concerned with generating clinical evidence than pursuing a full-scale launch. He noted that it is important for iRhythm and Verily to take the time to generate high-quality clinical evidence, as the reimbursement path for the watch will be driven by this data.
“As for when it transitions to full release, we’ll have to see how long evidence generation lasts,” Day said. “Our view is not about urgency, but about building this thoughtfully and ensuring that we can provide journal-level evidence as a basis for acceptance of this process by the clinical community.”
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