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.
![Images show the pectoralis muscles of a healthy male individual who never smoked (age, 66 years; height, 178 cm; body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], 28.4; number of cigarette pack-years, 0; forced expiratory volume in 1 second [FEV1], 97.6% predicted; FEV1: forced vital capacity [FVC] ratio, 0.71; pectoralis muscle area [PMA], 59.4 cm2; pectoralis muscle volume [PMV], 764 cm3) and a male individual with a smoking history and chronic obstructive pulmonary disorder (COPD) (age, 66 years; height, 178 cm; BMI, 27.5; number of cigarette pack-years, 43.2, FEV1, 48% predicted; FEV1:FVC, 0.56; PMA, 35 cm2; PMV, 480.8 cm3) from the Canadian Cohort Obstructive Lung Disease (i.e., CanCOLD) study. The CT image is shown in the axial plane. The PMV is automatically extracted using the developed deep learning model and overlayed onto the lungs for visual clarity.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/03/genkin.25LqljVF0y.jpg?auto=format%2Ccompress&crop=focalpoint&fit=crop&h=100&q=70&w=100)
![Images show the pectoralis muscles of a healthy male individual who never smoked (age, 66 years; height, 178 cm; body mass index [BMI, calculated as weight in kilograms divided by height in meters squared], 28.4; number of cigarette pack-years, 0; forced expiratory volume in 1 second [FEV1], 97.6% predicted; FEV1: forced vital capacity [FVC] ratio, 0.71; pectoralis muscle area [PMA], 59.4 cm2; pectoralis muscle volume [PMV], 764 cm3) and a male individual with a smoking history and chronic obstructive pulmonary disorder (COPD) (age, 66 years; height, 178 cm; BMI, 27.5; number of cigarette pack-years, 43.2, FEV1, 48% predicted; FEV1:FVC, 0.56; PMA, 35 cm2; PMV, 480.8 cm3) from the Canadian Cohort Obstructive Lung Disease (i.e., CanCOLD) study. The CT image is shown in the axial plane. The PMV is automatically extracted using the developed deep learning model and overlayed onto the lungs for visual clarity.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/03/genkin.25LqljVF0y.jpg?auto=format%2Ccompress&crop=focalpoint&dpr=2&fit=crop&h=167&q=70&w=250)
