![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Neurovascular Emergency AI Solution Cleared
Neurovascular Emergency AI Solution Cleared
![FDA clears text](https://www.fdanews.com/ext/resources/test/Drug-Images4/FDA-clears.gif?t=1619732616&width=430)
The FDA has granted 510(k) clearance for Avicenna.AI’s CINA Head, an artificial intelligence-based triage system for use in neurovascular emergencies.
The software evaluates computed tomography (CT) scans to automatically detect intracranial hemorrhaging and large vessel occlusions that can cause life-threatening strokes.
The product can help radiologists prioritize cases by estimating a patient’s stroke severity within 20 seconds, the company said.
Upcoming Events
-
21Oct