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# Livmor Wearable Halo AF Detection System Cleared
- URL: https://www.fdaweb.com/livmor-wearable-halo-af-detection-system-cleared/
- Published: 2020-10-15T12:00:00.000Z
- Updated: 2026-09-14T16:32:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147884

FDA has cleared a Livmor 510(k) for the Livmor Halo AF Detection System, a physician-prescribed wearable device that provides continuous monitoring of pulse rhythms for the detection of atrial fibrillation (AF), on demand during the day and automatically overnight. Continuous monitoring can significantly enhance the detection of paroxysmal (intermittent) or asymptomatic AF, the company says. The device is deployed on a Samsung daily wearable watch-like device, and because it is completely non-invasive the patient’s pulse rhythms recorded by the device can be analyzed for AF indefinitely, Livmor says.

The clearance was based on data from a multi-center clinical trial involving 269 patients that compared the accuracy of the Halo System with a concurrently recorded electrocardiogram (ECG), which is currently the gold-standard for measuring heart rhythms. “The ECG recordings were reviewed for accuracy by automated algorithms, ECG technicians, and cardiologists, and were subsequently compared to the concurrently recorded pulse rhythms from the Livmor Halo system,” the company says. Halo was shown to be 100% sensitive in identifying patients with AF and 93% specific in identifying patients without AF, it says.