IR-MED, a developer of non-invasive, AI-driven spectrographic technology, has launched an evaluation of its PressureSafe™ device at Methodist Healthcare in San Antonio, Texas.

The evaluation, titled "Safety and Efficacy of the PressureSafe Device for Early Detection of Pressure Injury in People with Various Skin Tones, Including Dark Skin Tones," has been approved and patient enrollment is underway.

Methodist Healthcare, which serves over 600,000 patients annually, is a prominent healthcare provider in the region.

PressureSafe™ uses infrared optical spectroscopy and AI algorithms to detect early-stage pressure injuries, making it effective for all skin tones by analyzing tissue beneath the skin's surface.

The device, listed with the FDA, aims to improve early detection, particularly for individuals with darker skin tones, who face a higher risk for pressure injuries.

The evaluation will involve up to 104 participants, with roughly half having darker skin tones. Wound care specialists (WOCN) will be trained to use PressureSafe™, and the device's effectiveness will be compared to standard visual assessments.

The goal is to enhance detection accuracy and reduce the incidence of pressure injuries, especially in populations with darker skin.

IR-MED considers this evaluation a key opportunity to showcase PressureSafe™'s potential to support healthcare staff, improve patient outcomes, and reduce costs.

A previous evaluation in Israel showed that the device had 92% sensitivity and 88% specificity, resulting in a 50% reduction in pressure injury incidence.

Pressure injuries are a major healthcare concern in the U.S., leading to approximately 60,000 deaths annually.

Treatment costs range from $20,900 to $151,700 per case, affecting around 2.5 million patients each year. These injuries are among the top causes of patient harm and a frequent subject of healthcare-related lawsuits.

 

Source: globenewswire.com

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