Avicenna.AI’s Stroke Severity Assessment Tool Receives FDA Clearance

Avicenna.AI (La Ciotat, France) announced that it received FDA 510(k) clearance for Cina-ASPECTS, an artificial intelligence (AI) tool that provides automatic assessment of stroke severity. Cina-ASPECTS automatically processes noncontrast CT scans and calculates ASPECTS (Alberta Stroke Program Early CT Score) values. The tool computes a heat map indicating the probability of hypodensity and sulcal effacement in the brain, displays a list of infarcted regions, and provides CT images corrected from tilt to easily compare the right and left hemisphere, according to a company statement.

In addition to assisting clinicians in the evaluation of ASPECTS from CT scans, Cina-ASPECTS also helps improve physicians’ reproducibility in ASPECTS value determination, which often varies depending on the radiologist reading the scan. The tool was validated on 200 scans acquired on 27 scanner models from four leading manufacturers.

Along with Cina-ASPECTS, the company’s portfolio includes other FDA-cleared AI solutions for medical emergencies: Cina-ICH for automatic detection of intracranial hemorrhage, Cina-LVO for large vessel occlusion, Cina-AD for aortic dissection, and Cina-PE for pulmonary embolism.

Neurointerventional news coverage produced in conjunction with Endovascular Today.