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Avicenna.AI secures FDA clearance for two healthcare AI solutions

Medical imaging AI company receives approval for algorithms enabling incidental detection of pulmonary embolism and automatic assessment of stroke severity.

La Ciotat, FRANCE, March 26, 2024 /PRNewswire/ — Medical imaging AI company Avicenna.AI today announced that it has received 510(k) clearance from the US Food and Drug Administration for its CINA-iPE and CINA-ASPECTS products. Using a combination of deep learning and machine learning technologies, the company develops AI solutions 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.

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