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FDA clears Livmor wearable for AF measurement
- October 28, 2020
- Steve Rogerson
Texas digital health company Livmor has received FDA 510(k) clearance for its Halo atrial fibrillation (AF) physician-prescribed wearable that provides continuous monitoring of pulse rhythms.
Continuous monitoring can significantly enhance the detection of paroxysmal (intermittent) or asymptomatic forms of AF. The Halo, deployed on a Samsung smartwatch, 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 analysed for AF indefinitely.
A multi-centre clinical trial was conducted with 269 enrolled patients, comparing the accuracy of the Halo in the processing of photoplethysmogram (PPG) signals recorded by the Samsung watch, with a concurrently recorded electrocardiogram (ECG), 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 with the concurrently recorded pulse rhythms from the Halo. The Halo was 100% sensitive in identifying patients with AF and 93% specific in identifying patients without AF.
AF is the most common form of abnormal heart rhythm among US adults with prevalence increasing with age, affecting 9% of US adults over 65. AF significantly increases risk of stroke, heart failure and vascular dementia, making early detection critical to prevent disease progression and life-threatening health consequences. Unfortunately, as many as half of patients with AF have no symptoms and are unaware of their significant health risks.
Subhash Banerjee, chief of cardiology at North Texas VA, said: “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.”
The Livmor AF detection system is FDA cleared class-II medical device software. It is powered by the FDA registered Halo+ home monitoring system that is provided to the patients pre-loaded and validated on a Samsung Gear S2 smartwatch with an integrated PPG monitor. Samsung Gear S2 is not FDA cleared for the detection of AF without Livmor controls.
“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,” said Ken Persen, founder and CEO of Livmor. “Starting today, medical professionals across the USA can prescribe our Halo, a patient-engaging and extendable system, for their at-risk patients. This is major step towards achieving our vision of a transformative patient-provider ecosystem that more proactively prevents, detects and manages chronic conditions.”
Founded in 2016, Livmor is a digital health company whose mission is to assist physicians and medical professionals in addressing the global chronic disease epidemic by providing a patient-engaging remote monitoring system of critical physiological biomarkers.
“With the increased need for remote care and monitoring, Samsung is committed to working with strategic partners to develop innovative digital health,” said Taher Behbehani, general manager at Samsung Electronics in America. “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.”