Sempulse® Breakthrough Wearable Device Receives FDA Clearance for Vital Signs Monitoring

Sempulse, a medical device manufacturer, announced on Monday that it had received clearance from the Food and Drug Administration for its Sempulse Halo Vital Signs Monitoring System, a miniature wearable device that can remotely monitor five major vital signs.

The durable, non-invasive system captures oxygen saturation levels, pulse rate, respiratory rate, core body temperature and skin temperature. It is designed for general monitoring, remote patient monitoring, telemedicine and chronic disease monitoring while patients are at rest or in motion.

The F.D.A. clearance marks a significant milestone for Sempulse in bringing its technology to market after years of development and testing. It is the first such clearance the company has received.

“Achieving F.D.A. clearance is the culmination of all of the hard work by the team over the past eight years and an exciting next step as people see and use our platform to save lives,” said Kurt Stump, chief executive of Sempulse. “From having our patents issued to the challenges of user testing with the Navy SEALs to monitoring patients during the pandemic, we have come a long way.”

The Halo monitor can be used in clinics, hospitals, emergency rooms, medical transports, homes and workplaces, including military medicine settings in the field. It is designed to be reusable, transportable and compatible with all types of ambulances, making it suitable for triage and trauma scenarios.

Complementing the Halo monitor are two other components of the Halo Platform: LiveCharts, an app that displays vital signs and prioritizes dozens of patients, and Command Cloud, a cloud-based software that centralizes vital signs management and allows remote medical resources to view and prioritize patients globally.

While millions of people use smartwatches and other consumer wearables to try to monitor their vital signs during daily activities, those devices do not provide medical-grade data and are not F.D.A. cleared. The Sempulse Halo aims to fill that gap by accurately providing vital signs across a range of use cases, including telemedicine visits where clinicians often lack access to such data for proper diagnoses.

Based in San Marcos, Sempulse has developed and patented a novel, non-invasive vital signs sensor that adheres to the neck and back of the ear. In addition to the five core vital signs, it can acquire geolocation data and environmental information.

The company plans to initially target its technology at the military and first responders but says its sensors are equally capable in civilian settings. A limited market release of the Halo device in the United States will begin in the coming weeks.