FDA OKs First Prescriptible Wearable for Continuous Heart Monitoring

LIVMOR Inc., a digital health solutions company, 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 atrial fibrillation (AF), on demand during the day and automatically overnight. Continuous monitoring can significantly enhance the detection of paroxysmal (intermittent) or asymptomatic forms of AF. The LIVMOR Halo System, deployed on a Samsung wearable, can be worn daily, and because it is completely non-invasive (no incisions, medical adhesives or electrodes) the patient’s pulse rhythms recorded by the device can be analyzed for AF indefinitely.
 
A multi-center clinical trial was conducted with 269 enrolled patients, comparing the accuracy of the LIVMOR Halo System, in the processing of photoplethysmogram (PPG) signals recorded by the Samsung wearable, with a concurrently recorded electrocardiogram (ECG), 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 LIVMOR Halo was 100 percent sensitive in identifying patients with AF and 93 percent specific in identifying patients without AF.
 
AF is the most common form of abnormal heart rhythm among US adults with prevalence increasing substantially with age, affecting 9 percent of US adults over 65.¹ AF significantly increases risk of stroke, heart failure and vascular dementia, making early detection critical to prevent disease progression and life-threatening health consequences.² Unfortunately, as many as half of patients with AF have no symptoms and are unaware of their significant health risks.³
 
Dr. Subhash Banerjee, Chief of Cardiology, North Texas VA, Co-principal Investigator: “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 clinically valuable monitoring for the management of the condition.”
 
Ken Persen, Founder & CEO, LIVMOR: “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.”
 
Taher Behbehani, GM & Head of Mobile B2B, Samsung Electronics America: “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.” 
 
References
¹ Camm AJ, Corbucci G, Padeletti L. Usefulness of continuous electrocardiographic monitoring for atrial fibrillation. Am J Cardiol. 2012 Jul 15;110(2):270-6. doi: 10.1016 / j.amjcard. 2012.03.021. Epub 2012 Apr 12.
² Sumeet S. Chugh, Rasmus Havmoeller, Kumar Narayanan, David Singh, Michiel Rienstra, Emelia J. Benjamin, Richard F. Gillum, Young-Hoon Kim, John H. McAnulty Jr, Zhi-Jie Zheng, et al. Worldwide Epidemiology of Atrial Fibrillation A Global Burden of Disease 2010 Study. 17 Dec 2013 Circulation. 2014;129: 837–847
³ Rienstra M, Vermond RA, Crijns HJ, et al. Asymptomatic persistent atrial fibrillation and outcome: results of the RACE study. Heart Rhythm. 2014;11(6):939-945.