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.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
