Since the 1960s, wearable technology has evolved from portable transistor radios and wristwatch calculators to everyday haptic clothing and fitness monitors. The wearable wave first took over the world through commercial devices designed to assist hobbyists and professionals in fitness and sports. Most wearables sense and record basic physiological functions like heart rate, respiratory rate, sleep cycles, and overall physical activity. They have therefore been seen as having limited potential in a real clinical or diagnostic context.
Surprisingly, in the last decade, healthcare has emerged as an important beneficiary of today’s increasingly sophisticated fitness and wellness trackers. Researchers discovered that the parameters monitored by wearables could contribute to identifying individuals at risk of specific medical conditions. For instance, irregular pulse rates as recorded by wearables have been shown to help identify a complex heart condition called atrial fibrillation (AF) that often manifests without symptoms and goes unnoticed in the critical early stages.
With more research into new applications of wearables, especially in cardiac health management, wearable technology has adapted rapidly to new challenges. The United States Food and Drug Administration (FDA) considers these devices no replacement to traditional diagnosis by a physician and at most having prediagnostic value. That is, while wearables cannot reliably diagnose a condition, they can help in screening for people who may be at risk of the condition. Through the course of daily activity, the device users could be alerted to unusual or erratic measures that would have otherwise gone unrecognized, thus prompting a visit to the doctor. With the rare exception of a few smartphone-linked heart rate monitors, no wearables have received the requisite FDA accreditation to be used as medical devices. Until now, that is.
LIVMOR, Inc., a. Texas-based digital health solutions company, has received FDA clearance for a continuous heart monitoring wearable that can be prescribed by a physician. The LIVMOR Halo™ AF Detection System comprises the medical software, called the LIVMOR Halo +™ home monitoring system, integrated into the Samsung Gear S2 Smartwatch. This system continuously monitors pulse rhythms throughout the day to flag indicators of AF, even when the condition is asymptomatic or intermittent.
Dr. Subhash Banerjee, North Texas VA, a co-principal investigator in the clinical trial for the system identified the goal of their efforts to be cost-effective and clinically valuable monitoring of AF. Ken Persen, Founder & CEO, LIVMOR referred to this milestone as a major step toward achieving a “transformative patient-provider ecosystem that more proactively prevents, detects, and manages chronic conditions.”