Main menu


iRhythm gets FDA approval for AFib characterization algorithm used in Verily wearables

On Friday, Food and Drug Administration Another permit 510 (k) clearance To iRhythm Technologies AI-powered software system designed for use in veryof Irregular pulse tracking clock..

The ZEUS (Zio ECGUtilization Software) system, trained to monitor atrial fibrillation (AFib), has several licenses. FDA website.. The latest clearance is for an algorithm that classifies a patient’s atrial fibrillation by analyzing how much atrial fibrillation the patient experiences over time.

iRhythm Technologies is a San Francisco-based arrhythmia diagnostics company. Published In 2016, we achieved an IPO of $ 107 million. For the past two years, we have worked with Verily to develop the ZEUS system in collaboration with Verily watches. Also, FDA approval..The goal of collaboration is According to iRhythm Chief Technology Officer Mark Day, it’s about creating AFib monitoring wearables that clinicians take seriously, rather than treating them like consumer technology.

Berilly watches are prescription medical devices for long-term, non-invasive and continuous monitoring of AFib. Wearables are based on Photopretismography (PPG), which measures the volume change in blood circulation using a light source and a photodetector on the patient’s skin. An algorithm recently approved by the FDA uses its detection to characterize the amount of AFib that occurs over time. The iRhythm metric is called “AFib Burden”.

The ZEUS system sends an estimate of the patient’s AFib load directly to the physician for interpretation and treatment management with the aim of assisting the patient in more timely and appropriate treatment. iRhythm has trained algorithms on what it believes to be the largest repository of labeled ECG data in history for over a billion hours.

“This is not only raw ECG data, but also curated ECG data,” Day pointed out. “That’s our core business right now. It’s a description of ECG curation, labeling, and the exact period that triggers AFib in ECG.”

Today, the fact that the system sends information directly to the doctor, not the patient, is important. This distinguishes the ZEUS system and Verily watches from other AFib detection wearables such as: Apple watchHe said.

“We don’t just provide the information, we provide it directly to our doctor,” Day declared. “This is the opposite of providing it to consumers. Consumers need to understand how to provide this information to their doctors.”

Despite FDA approval, neither Verily watches nor ZEUS systems are commercially available.

According to Day, the system is being validated by a study of 120 patients who collected data on people aged 65 and over in a walking environment. He said iRhythm is pursuing these trials further and the company is currently more interested in generating clinical evidence than pursuing full market launch. He said it is important for iRhythm and Verily to take the time to generate quality clinical evidence, as the reimbursement pathway for the watch is determined by this data.

“We need to see how long evidence generation will last for the exact time it will turn into a full launch,” says Day. “We have a great deal of perspective, not urgency, but a careful construction of this so that we can provide journal-level evidence that serves as the basis for embracing this process in the clinical community.”

Photos: mediaphotos, Getty Images