Medical artificial intelligence (AI) software developer CuraCloud has received U.S. Food and Drug Administration (FDA) 510(k) clearance for CuraRad-ICH, a computer-aided triage and notification application for detecting intracranial hemorrhage (ICH) on head CT scans.
Designed to aid in prioritizing the clinical assessment of adult noncontrast head CT cases with features suggestive of acute ICH, the software employs deep-learning algorithms to analyze cases, according to the vendor. It then outputs its findings on a case level to a PACS workstation for worklist prioritization or triage purposes, CuraCloud said.
The firm said that CuraRad-ICH was trained and validated using CT images from more than 300 imaging facilities in almost all states of the U.S. The software's core AI engine takes an average of about 20 seconds to process each case.
The FDA clearance is the first for CuraCloud. The company said that it's also developing a portfolio of other AI-powered software for use in the U.S. and the rest of the world.
