MTEC Announces the FDA Clearance of the Sempulse® Halo™ Vital Signs Monitoring System
MTEC (The Medical Technology Enterprise Consortium) announced the FDA 510(k) Clearance of the Sempulse® Halo™ Vital Signs Monitoring System, a non-invasive, miniature vital signs monitor, mobile app, Cloud solution, and support system. The Halo is the first multiparameter vital signs monitor of its kind cleared by the FDA and includes work, sport, and ambulatory monitoring. They also detailed the SBIR grants that Sempulse participated in on its FDA journey, including COVID-19 pandemic-related projects with the US Army and US Air Force and the early detection of hemorrhagic decompensation.
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.
About MTEC: The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium that is internationally-dispersed, collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Development Command. The consortium focuses on the development of medical solutions that protect, treat, and optimize the health and performance of U.S. military personnel and civilians.