STAT+: FDA clears AI to detect 14 conditions from CT. What’s next?

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Source: STAT News

Original: https://www.statnews.com/2026/01/22/fda-clears-ai-tool-multiple-conditions-healt...

Published: Thu, 22 Jan 2026 14:25:26 +0000

The FDA has approved artificial intelligence tools from Avicenna.AI to detect 14 conditions from CT scans[1][5]. The company received 510(k) clearance for the products CINA-iPE and CINA-ASPECTS[1]. CINA-iPE identifies blood clots in the lungs on routine CT scans, including whole body, chest, abdomen and pelvis[1]. The tool was validated on 381 CT scans from 39 different scanner models from five manufacturers with high sensitivity and specificity[1]. CINA-ASPECTS is the first FDA-approved computer-aided diagnosis (CADx) tool to assess the severity of a condition[1]. These tools complement previous AI solutions for detecting intracranial hemorrhage, large vessel occlusion, aortic dissection, and pulmonary embolism[1]. All integrate into radiologists' workflow and automatically report results[1]. As of September 2023, the FDA had approved 237 AI devices in radiology[2].