IR-Med Inc. announced its PressureSafe decision support device has received U.S. Food and Drug Administration (FDA) listing or the indication of pressure injuries. PressureSafe is classified as a Class I device and is exempt from 510(k) premarket submission. PressureSafe uses infra-red spectroscopy combined with an AI-based algorithm for the early, non-invasive, and skin color agnostic detection of pressure injuries with real-time analysis at the point of care.

PressureSafe achieved 92% efficacy in the early, non-invasive detection of pressure injuries, regardless of skin color, in a study conducted in Israel with the world?s second largest HMO, Clalit. Nearly 1,500 scans were performed on 154 body locations. In the U.S. alone, 60,000 patients die every year as a direct result of pressure injuries.

Patient care cost per pressure injury ranges from $20,900 up to $151,700, for the 2.5 million patients per year who develop pressure injuries. Pressure injuries are one of the five most common harms experienced by patients and the second most common claim for lawsuits after wrongful death.