MedyMatch Technology, medical artificial intelligence (AI) company, announced it has been granted Expedited Access Pathway (EAP) designation by the U.S. Food and Drug Administration for intracranial hemorrhage detection software, according to a Jan. 30 press release by the company.
The software automatically analyzes non-contrast head CT images and is designed with amplified sensitivity to the presence of intracranial hemorrhage (ICH). Treating physicians are subsequently alerted when ICH is detected in a patient.
"FDA's Expedited Access Pathway and Breakthrough Device designation gives us the opportunity to accelerate the development and approval process of our intracranial hemorrhage software in the United States," said Joshua Schulman, MD and vice president of clinical, regulatory and quality affairs at MedyMatch in the release. "This designation is a recognition of both the need for new assessment tools for intracranial hemorrhage and an affirmation of MedyMatch's technical approach to assisting clinicians who need to make time-sensitive yet accurate decisions in emergency settings. We look forward to working with FDA to bring the ICH application to market quickly."
Intracranial hemorrhage detection software is the first application of the company’s broader AI and deep learning platform.