IR-MED’s PressureSafe is currently undergoing usability studies and is not yet available for commercial use. Image Credit: Robert Kneschke / Shutterstock.

Israel-based IR-MED has announced positive results from the usability study of its pressure injury detection device, PressureSafe.

PressureSafe uses AI to analyse the infrared spectrographic data collected by the device to detect the presence of pressure injuries. It received a listing as a Class I decision support device from the US Food and Drug Administration (FDA) last month. As part of the Class I device tag, the device is exempt from 510(k) premarket submission in the US.

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The usability study was carried out in Israel at two medical centres owned by Clalit – the largest of the country’s four state-mandated health service organisations. A total of 924 scans were conducted on 154 body locations as part of the trial.

The PressureSafe device demonstrated 92% sensitivity and 88% specificity in detecting suspected or Stage I deep tissue injury (sDTI) pressure injuries. During the study period, PressureSafe helped reduce the incidence of pressure injuries by 50%, compared to the levels before the study.

Pressure injuries are ulcers (sores) which can develop in patients with limited or no mobility who are either bedridden, unconscious or unable to sense pain. The current standard for diagnosing pressure injuries is a visual examination, but this can be harder to do in people with darker skin tones.

A study estimates that approximately one to three million people have pressure injuries in the US, with 5%-15% of patients in long-term intensive care suffering from these ulcers.

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The adoption of generative AI in the medical devices sector has been steadily increasing in the past few years. A GlobalData report forecasted that the AI market will be worth $909bn by 2030.

GobalData is the parent company of Clinical Trials Arena.

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