Sempulse® announces U.S. FDA 510(k) Clearance and the Commercial Launch of the Halo™ Vital Signs Monitoring System

Sempulse today announced U.S. Food and Drug Administration (FDA) 510(k) clearance and the commercial launch of the Sempulse Halo Vital Signs Monitoring System. The miniature wearable device is a durable, non-invasive, remote vital signs monitoring system that captures 5 major vital signs (SpO₂, pulse rate, respiratory rate, core body temperature, and skin temperature) for general monitoring, Remote Patient Monitoring (RPM), telemedicine, and chronic disease monitoring while at rest or in motion.

FDA-Cleared Halo System

It is the first FDA clearance the company has received. The Halo monitor may be used in clinics, hospitals, emergency rooms, medical transports, the home, and the workplace, including military medicine settings in the field. The Halo monitor is capable of being used during triage and trauma scenarios and is reusable, transportable, and for use in all types of ambulances. Also included in the Halo Platform are LiveCharts and Command Cloud. LiveCharts is an app that enables the Halo monitor.

It displays vital signs and prioritizes dozens of patients. Command Cloud is cloud-based software that centralizes vital signs management and allows remote medical resources to view and prioritize patients around the globe. Kurt Stump, CEO of Sempulse, remarked that “achieving FDA 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.

Medical Device Advancements

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. We officially launch our Halo Platform and the Halo device with great momentum to undertake deployments with the U.S. Military and forward-thinking police and fire departments later this year.” Millions of people use smart watches and other wearables in an attempt to monitor themselves while in motion throughout the day, but those devices do not provide medical-grade data and are not FDA cleared.

Millions more attend telemedicine visits every year without accurate vital signs for a clinician to properly diagnose them. Even more are not monitored while they work or recover. The Sempulse Halo can accurately provide vital signs for all of these use cases. Sempulse is a medical device manufacturer with offices in San Marcos, TX.

Innovative Vital Signs

They have developed and patented a novel, non-invasive vital signs sensor that adheres to the neck and the back of the ear and acquires multiple patients’ vital signs, including SpO₂, pulse rate, respiratory rate, core body temperature, and skin temperature, plus geolocation and a wealth of environmental information. They are first targeting their technology at the military and first responders, but their sensors are equally capable in the civilian world. Limited market release of the device in the U.S. will begin in the coming weeks.