IR-MED Launches Usability Study of PressureSafe™ at Methodist Healthcare
IR-MED Inc. has begun a usability study of its PressureSafe™ device at Methodist Healthcare. The goal is straightforward: make it easier to catch pressure injuries early—before they escalate. These injuries affect millions each year, and earlier, more reliable detection can change outcomes in meaningful ways.
PressureSafe™: How It Works and Why It Matters
PressureSafe™ uses a non-invasive method that combines infrared optical spectroscopy with an advanced AI-driven algorithm. Instead of relying only on what the eye can see, the device analyzes changes in biomarkers just beneath the skin’s surface. By doing so, it’s designed to flag pressure injuries early and consistently, regardless of a patient’s skin tone. That approach offers a more precise signal than standard visual checks alone.
The Stakes: Pressure Injuries Today
Pressure injuries carry a heavy toll. In the U.S., prevention and treatment are estimated to cost $26.8 billion annually. They’re also linked to approximately 60,000 deaths each year. And the burden isn’t evenly shared: research shows people with darker skin tones are more than twice as likely to experience pressure injuries, exposing a gap in monitoring that visual assessment alone often can’t close.
Study Design and Implementation
The Methodist Healthcare study will enroll up to 104 participants, with a deliberate effort to include a balanced representation of individuals with darker skin tones. Trained wound care specialists will operate the PressureSafe™ device in routine care settings. The study will assess how the device performs by measuring sensitivity and specificity—how accurately it detects early-stage pressure injuries and how well it avoids false positives—compared with traditional visual assessments by clinicians.
Expert Insight from Methodist Healthcare
Dr. Mary Lee Potter, Director of Professional Nursing Practice at Methodist Healthcare and a key leader of the study, underscores why this work matters: more accurate, earlier detection can improve care at the bedside. She’s eager to see how PressureSafe™ might sharpen clinical decision-making and support teams working to prevent avoidable harm.
What the Findings Could Mean
This study is a milestone for IR-MED and for clinicians looking for better tools to reduce pressure injuries. Dr. Yaniv Cohen, IR-MED’s Co-Founder and Chief Science Officer, welcomes the collaboration with Methodist Healthcare and expects the results to show how PressureSafe™ can support healthcare professionals in their daily practice.
Earlier Results and What Comes Next
Previous trials in Israel found that PressureSafe™ detected pressure injuries with 92% sensitivity. Those results highlight the device’s potential and lay groundwork for validation within the U.S. healthcare system. The current study aims to build on that foundation by evaluating performance in a broader clinical environment.
About IR-MED
IR-MED develops technologies for real-time, non-invasive analysis of biological markers in tissues. PressureSafe™ is its first product, created to help clinicians identify and manage pressure injuries across all skin tones more effectively. With patented innovations behind it, IR-MED is focused on practical tools that fit into care teams’ workflows and help patients receive timely, equitable care.
Frequently Asked Questions
What is the main purpose of the PressureSafe™ usability study?
The study is designed to evaluate how well PressureSafe™ detects early pressure injuries in real clinical settings and across different skin tones. By comparing device results with traditional visual assessments, the team aims to see whether earlier, more reliable detection can support better patient outcomes.
How does PressureSafe™ work?
PressureSafe™ combines infrared optical spectroscopy with an AI-driven algorithm to analyze biomarkers just beneath the skin’s surface. Because it doesn’t depend solely on visual cues, it can help spot early changes that might be missed during routine inspections, and it does so non-invasively.
Who is conducting the usability study?
The study is being conducted at Methodist Healthcare. It’s led in part by Dr. Mary Lee Potter, Director of Professional Nursing Practice, working with trained wound care specialists who use the PressureSafe™ device at the point of care.
What results are expected from this study?
IR-MED anticipates evidence that PressureSafe™ can detect pressure injuries with high sensitivity and strong overall performance when compared to visual assessment alone. The team is especially focused on consistent detection across skin tones to help close known gaps in care.
Why are pressure injuries such a persistent challenge?
They’re costly, deadly, and often underdetected early on. In the U.S., they account for an estimated $26.8 billion in annual costs and are linked to about 60,000 deaths each year. People with darker skin tones are more than twice as likely to experience these injuries, which makes more reliable, equitable detection methods essential.
