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IR-MED’s PressureSafe device reduces the incidence of pressure injuries by half

Posted on by darion

IR-MED’s PressureSafe solution is currently undergoing usability testing and is not yet available for commercial use. Photo credit: Robert Kneschke / Shutterstock.

The Israeli company IR-MED announced positive results of a usability study of its PressureSafe pressure injury detection device.

PressureSafe uses artificial intelligence to analyze infrared spectrographic data collected by the device to detect the presence of pressure ulcers. Last month, it received a Class I decision-support device listing from the U.S. Food and Drug Administration (FDA). As part of the Class I device tag, the device is exempt from US 510(k) premarket notification requirements.

The usability study was conducted in Israel in two medical centers belonging to Clalit – the largest of the four state organizations providing health services. A total of 924 scans of 154 body locations were performed as part of the study.

The PressureSafe device was 92% sensitive and 88% specific in detecting pressure injuries suspected to be deep tissue injury (sDTI) or Grade I. During the study period, PressureSafe helped reduce the incidence of pressure injuries by 50% compared to pre-study levels.

Pressure sores are sores (pressure sores) that can develop in patients with limited or no mobility, who are bedridden, unconscious or unable to feel pain. The current standard for diagnosing pressure ulcers is visual examination, but this may be more difficult in darker-skinned people.

The study estimates that approximately 1 to 3 million people in the U.S. suffer from pressure injuries, with 5% to 15% of long-term intensive care patients suffering from this type of ulcer.

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