Avicenna.AI secures FDA clearance for CINA-iPE and CINA-Aspects

Medical imaging AI company Avicenna.AI has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CINA-iPE and CINA-Aspects software.

CINA-iPE is an AI-powered tool that detects incidental pulmonary embolism during routine CT scans. The algorithm identifies lung blood clots detected during routine CT scans for a variety of health conditions. Scan types may include full-body scans, scans of the chest, abdomen, and pelvis, as well as scans of the thoracic area along with the abdomen and pelvis.

CINA-Aspects is for stroke severity assessment, automatically processing non-contrast CT scans and calculating the “Aspect” score. It is a topographic scoring system that quantifies the severity of a stroke from a CT scan of the brain. The software creates 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 hemispheres.

Additionally, CINA-Aspects also helps improve physicians’ reproducibility in Aspect scoring, which often varies depending on the radiologist reading the scan, the company noted.