LIVMOR Halo AF Detection System Receives 510(k) Clearance from FDA
The LIVMOR Halo AF Detection System has received 510(k) clearance from the US FDA and becomes the first prescriptible wearable for continuous heart monitoring in patients with atrial fibrillation.
LIVMOR Inc. has announced their wearable solution for continuous heart monitoring, the LIVMOR Halo AF Detection System received 510(k) clearance from the US Food and Drug Administration (FDA)—making it the first prescriptible wearable for continuous heart monitoring, according to a statement from LIVMOR.
Deployed through a Samsung wearable device, the LIVMOR Halo System provides continuous monitoring of pulse rhythms for detecting atrial fibrillation (AF) and is backed by on the results of a clinical trial with more than 250 patients.
"The FDA 510(k) clearance of our LIVMOR Halo™ AF detection system (deployed as an integrated part of the LIVMOR Halo+™ Home Monitoring system powered by Samsung) is a significant milestone for LIVMOR and serves as a foundational cornerstone in our Samsung-based digital health platform,” said Ken Persen, founder and chief executive officer with LIVMOR, in a statement. “Starting today, medical professionals across the US can prescribe our LIVMOR Halo™, a patient-engaging and extendable system, for their at-risk patients. This is major step toward achieving our vision of a transformative patient-provider ecosystem that more proactively prevents, detects, and manages chronic conditions."
According to LIVMOR, the Halo System was examined in a multicenter trial comprised of 269 patients that compared the system to concurrently record electrocardiograms. In the trial, ECG recordings were reviewed for accuracy by ECG technicians, cardiologists, and automated algorithms. Results of the trial suggest LIVMOR Halo was 100% sensitive in identifying patients with AF and 93% specific in identifying patients without AF.
“The goal of LIVMOR’s AF detection monitor is to provide cost-effective systemic population monitoring for patients susceptible to having atrial fibrillation, particularly those with paroxysmal or asymptomatic forms of AF and also for those with a prior diagnosis of AF, to provide monitoring clinically useful for the management of the condition.”
This is a developing story and will be updated when more information becomes available.
