The artificial intelligence sector is currently the most talked about and perhaps understandable, given its long-term potential. If you are currently looking into the sector, then one of the companies that could be worth tracking could be IR-MED Inc. (OTC:IRME). The company is best known for having developed a non-invasive, artificial intelligence-powered spectrographic analysis technology platform meant for addressing healthcare-related needs.
On April 5, the company announced that its decision support device, PressureSafe, had been awarded the status of an indication for pressure injuries by the United States Food and Drug Administration. It was also revealed that PressureSafe had been classified as a Class I device and hence was exempt from 510 (K) premarket submission. The product deploys infrared spectroscopy along with an artificial intelligence-powered algorithm for the purpose of providing non-invasive, early, and skin-color-agnostic detection of pressure-related injuries. It also provides real-time analysis of the same at the point of care.
The Chief Technology Officer and interim Chief Executive Officer of IR-MED, Ronnie Klein, spoke about the latest developments as well. He stated that the regulatory breakthrough was a major step forward in the company’s aim of launching the product commercially in the United States. Additionally, he noted that the milestone was also a demonstration of the commitment of IR-MED to taking patient safety and care forward through leading-edge medical devices.
He went on to state that the company had conducted usability studies of the product in Israel and had decided to expand the studies to the United States. The studies in the United States would commence through a wide hospital network and would begin this year. The PressureSafe device had clocked efficacy levels of as much as 92% in the early and non-invasive detection of pressure injuries in the study conducted in Israel.
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