Livmor announced today that it received FDA 510(k) clearance for its Livmor Halo wearable AFib detection system.
Dallas-based Livmor’s Halo AFib detection system is a physician-prescribed wearable device for continuously monitoring pulse rhythms to detect AFib on-demand during the day and automatically overnight, according to a news release.
Halo is deployed on a Samsung wearable device and, because it is a non-invasive system, it can record the patient’s pulse rhythms and analyze for AFib indefinitely.
Livmor conducted a 269-patient trial to compare Halo’s accuracy in the processing of photoplethysmogram (PPG) signals recorded by the wearable while also recording electrocardiogram (ECG), which is currently the standard for measuring heart rhythms.
ECG recordings were reviewed for accuracy and compared to the concurrently recorded rhythms from the Halo system. The Halo was 100% sensitive in identifying patients with AFib and 93% specific in identifying patients without AFib.
“The FDA 510(k) clearance of our Livmor Halo AFib 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,” Livmor founder & CEO Ken Persen said in the release. “Starting today, medical professionals across the U.S. can prescribe our Livmor Halo, a patient-engaging and extendable system, for their at-risk patients. This is a major step toward achieving our vision of a transformative patient-provider ecosystem that more proactively prevents, detects, and manages chronic conditions.”