Medical imaging AI company Avicenna.AI has obtained U.S. FDA 510(k) clearance for its CINA-iPE and CINA-ASPECTS products. These products use deep learning and machine learning technologies to automatically detect and prioritize life-threatening conditions within seconds, assisting clinicians in timely assessment.

CINA-iPE is specifically designed to address delayed and overlooked findings in diagnostic imaging by detecting incidental pulmonary embolism during routine CT scans. This is crucial because only a small percentage of emboli are initially reported, despite being commonly found during chest CT scans. This issue is particularly important in cancer patients, where pulmonary embolism is a significant contributor to mortality.

Specifically, the CINA-iPE algorithm identifies lung blood clots detected during routine CT scans for entirely different health conditions. Scan types may include full-body scans, scans of the chest, abdomen, and pelvis, and scans of the thoracic area along with the abdomen and pelvis. The tool was validated on 381 CT scans (performed for other clinical indications than for pulmonary embolism evaluation) acquired on 39 different scanner models from five manufacturers, achieving high sensitivity and specificity.

“From day one, we have been committed to validating our AI tools on every type of CT scanner,” adds Yasmina Chaibi, clinical affairs manager at Avicenna.AI. “In our validation studies, CINA-iPE achieved excellent sensitivity and specificity, demonstrating its ability to provide effective prioritization and triage on routine CT scans performed for other clinical indications than pulmonary embolism suspicion.”

Moreover, CINA-ASPECTS is an AI tool for stroke severity assessment, automatically processing non-contrast CT scans and calculating the “ASPECT” score, a topographic scoring system used to quantify the severity of a stroke from a CT scan of the brain. 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.

“We are delighted to launch CINA-ASPECTS to the U.S. market, marking a significant milestone as our first CADx product receives FDA clearance,” says Stéphane Berger, regulatory and quality manager. “We take pride in being at the forefront of CADx solutions, being the first AI company supported by thorough clinical validation and a rich repository of real-world clinical data, which ensures compatibility across all manufacturers and platforms.”