Avicenna.AI Receives FDA Approval for CINA-iPE and CINA-ASPECTS AI Solutions

La Ciotat, France-based Avicenna.AI has received 510(k) clearance from the US FDA for CINA-iPE and CINA-ASPECTS, two AI solutions based on a combination of deep learning and machine learning technologies that automatically detect and prioritize life-threatening conditions within seconds, assess them for severity, and seamlessly notify clinicians.

Addressing the serious issue of delayed and missed findings in diagnostic imaging, CINA-iPE is an AI-powered tool that detects incidental pulmonary embolism during routine CT scans. Unsuspected pulmonary embolism is a common finding in routine CT scans of the chest, but as little as 25% of emboli are reported during the initial interpretation. This is particularly relevant in the cancer patient population, where pulmonary embolism is a significant cause of mortality.

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 leading manufacturers, achieving excellent sensitivity and specificity.

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.

CINA-ASPECTS also helps improve physicians’ reproducibility in ASPECT scoring, which often varies depending on the radiologist reading the scan. The tool was rigorously validated on 200 scans acquired on 27 scanner models from four leading manufacturers.

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. The validations and multi-reader-multi-case studies we conducted highlighted that CINA-ASPECTS not only obtained outstanding standalone performance, but also demonstrated that its adjunctive use significantly improved clinicians’ accuracy in the assessment of ASPECTS regions, compared to the conventional use of NCCT images alone,” said Yasmina Chaibi, Clinical Affairs Manager at Avicenna.AI.

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