Sempulse has recently announced the FDA clearance for its Halo Vital Signs Monitoring System. The development of this system was supported by Military Infectious Disease Research Program, Military Operational Medicine Research Program, and the Medical Technology Enterprise Consortium (MTEC).
Sempulse’s Halo Physiologic Monitoring Platform (PMP) is designed for remote, real-time monitoring of multiple subjects, including the early detection of hemorrhagic decompensation, a primary cause of mortality in military and civilian trauma cases. Its remote monitoring capabilities with medical-grade biometric data acquisition paired with its advanced decision support software allowed this wearable physiologic monitoring device to be uniquely qualified for the early detection of SARS-CoV-2 infection. With this application in mind, Sempulse was funded through MTEC during the pandemic to further develop its non-invasive wearable for identifying and isolating pre-symptomatic COVID-19 cases for preventing the spread of the virus.
Upon successful completion of this project, Sempulse continued to refine and further develop the system through its FDA regulatory approval. The new Halo monitor is approved to 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, is reusable, and transportable making it ideal for use in all types of ambulances. Also included in the Halo Platform are LiveCharts, an app available on the App Store that enables the monitoring of vital signs for dozens of patients, and Command Cloud, a centralized vital signs and patient management system and allows centralized, remote medical resources to view and prioritize patients around the globe.
Future FDA clearances will bring additional vital signs to this platform with only the need for software updates. Sempulse is actively marketing the product across multiple branches of the Department of Defense (DoD). Highlights include its use in field triage and Tactical Combat Casualty Care (TCCC), human performance optimization (HPO), telemedicine, duty monitoring for heat and other injuries, aircrew monitoring, and pilot candidate monitoring. Similar use cases are being piloted with foreign, friendly militaries and other branches of the U.S. Government. Civilian use cases currently include police forces, fire departments, Emergency Medical Services (EMS), Mobile Integrated Healthcare (MIH), and worker safety monitoring.
Sempulse was selected for award from the respondents to MTEC’s Request for Project Proposals soliciting medical technological solutions related to MTEC’s Technology Focus Areas (Solicitation #MTEC-20-12-COVID19-Diagnostics).
About Sempulse: Sempulse is a medical device manufacturer with offices in San Marcos, TX. 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, skin temperature, activity, and a wealth of environmental information. They are first targeting their technology at the military and first responders, but their vital signs monitors are equally capable in the civilian world. 
