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The LIVMOR Halo AF Detection SystemTM is indicated for use by patients who have been diagnosed with or are susceptible to developing atrial fibrillation and who would like to monitor and record their pulse rhythms on an intermittent basis so that their physician can be alerted irregular heart rhythms. The LIVMOR Halo AF Detection System is intended for use in conjunction with the LIVMOR Halo+ Home Monitoring SystemTM, and is not validated for use with other pulse monitoring systems.

The LIVMOR Halo AF Detection System™ consists of an algorithm to filter and detect irregular pulse rhythm that may be suggestive of atrial fibrillation (AF) from photoplethysmograph (PPG) data, a patient user interface to notify the patient of data collection, and a physician user interface to alert the physician when irregular pulse rhythm suggestive of AF is detected. This medical device software interfaces with the LIVMOR Halo+ Home Monitoring System™ and compatible smartwatch to capture PPG data and sync to servers. The LIVMOR Halo AF Detection System is designed to intermittently monitor for irregular heart rhythm using the LIVMOR Halo+ Home Monitoring System while the user is at rest at night. Photoplethysmograph (PPG) signals recorded by the Halo Watch are then analyzed by the Halo AF Detection System when WiFi connectivity is available. The signal is first analyzed for quality before performing the analysis. The complete set of data from the recording session is analyzed. When a signal is suggestive of AF, the rhythm is flagged for physician review through the LIVMOR Heatt View physician portal.