IR-MED’s PressureSafe™ Receives FDA Listing for the Indication of Decision Support Device for Pressure Injuries
Rosh Pina, Israel, April 05, 2024 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive artificial intelligence (AI) driven spectrographic analysis technology platform to address significant healthcare needs, today 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.
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