First prescriptible, wearable system for continuous heart monitoring nets FDA clearance
LIVMOR, Inc. announced that it received FDA 510(k) clearance for the LIVMOR Halo AF Detection System, a physician-prescribed wearable solution that provides continuous monitoring of pulse rhythms for the detection of AF.
Continuous monitoring can significantly enhance the detection of paroxysmal or asymptomatic AF, on demand during the day and automatically overnight, according to a company press release.
The LIVMOR Halo System is deployed on a Samsung wearable. It can be worn daily and is completely noninvasive. The patient’s pulse rhythms recorded by the device can be analyzed for AF indefinitely, according to the release.
A multicenter clinical trial was conducted with 269 enrolled patients to compare the accuracy of the LIVMOR Halo System, in the processing of photoplethysmogram (PPG) signals recorded by the Samsung wearable, with a concurrently recorded ECG. The ECG recordings were reviewed for accuracy by automated algorithms, ECG technicians and cardiologists, and were subsequently compared with the concurrently recorded pulse rhythms from the LIVMOR Halo System. The LIVMOR Halo System was 100% sensitive in identifying patients with AF and 93% specific in identifying patients without AF, according to the release.
“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,” Subhash Banerjee, MD, FACC, chief of cardiology at North Texas VA, said in the release.
Ken Persen, founder and CEO of LIVMOR, said: “The FDA 510(k) clearance of our LIVMOR Halo AF detection system ... is a significant milestone for LIVMOR and serves as a foundational cornerstone in our Samsung-based digital health platform. 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 forward achieving our vision of a transformative patient-provider ecosystem that more proactively prevents, detects and manages chronic conditions.”
“With the increased need for remote care and monitoring, Samsung is committed to working with strategic partners to develop innovative digital health solutions. We are thrilled that LIVMOR’s secure AF detection monitor on Samsung wearables has achieved this significant milestone, helping clinicians reach even more patients with potentially lifesaving technology,” Taher Behbehani, GM and head of Mobile B2B at Samsung Electronics America, said in the release.