LIVMOR Halo is said to be the world's first prescriptible wearable device for continuous heart monitoring
Digital health solutions company LIVMOR has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Halo atrial fibrillation (AF) detection system.
LIVMOR Halo is claimed to be the world’s first prescriptible wearable device for continuous heart monitoring.
The physician-prescribed wearable solution has been developed to offer continuous monitoring of pulse rhythms for the detection of AF.
LIVMOR Halo deployed on Samsung wearable device
Designed to deploy on a Samsung wearable device, LIVMOR Halo system can be worn daily and it is completely non-invasive. The pulse rhythms of the patient recorded by the device can be frequently analysed for AF.
The company carried out a multi-centre clinical study with 269 patients to compare the accuracy of the Halo system in the processing of photoplethysmogram (PPG) signals recorded by the Samsung wearable with a concurrently recorded electrocardiogram (ECG).
ECG technicians, cardiologists and automated algorithms have been used for ECG recordings, and were subsequently compared to the concurrently recorded pulse rhythms from the LIVMOR Halo system.
The LIVMOR Halo AF system was found to be 100% sensitive in identifying patients with AF and 93% specific in identifying patients without AF.
LIVMOR founder and CEO Ken Persen said: : “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.
“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.”
In August this year, Abiomed secured emergency use authorisation (EUA) from the FDA or its left-sided Impella heart pumps to support therapy for Covid-19 patients.