FDA clears AI-driven detection tool for pulmonary embolism – Vascular News

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Medical imaging AI company Avicenna.AI has announced 510(k) clearance from the US Food and Drug Administration (FDA) for its CINA-iPE artificial intelligence (AI)-powered tool that detects incidental pulmonary embolism (PE) during routine computed tomography (CT) scans.

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 PE evaluation—acquired on 39 different scanner models from five leading manufacturers, “achieving excellent sensitivity and specificity,” according to Avicenna AI.

“From day one, we have been committed to validating our AI tools on every type of CT scanner,” said 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.”

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