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Stroke Decision-Support Software Gets US Approval

While US FDA works on a new guidance for clinical decision support software, the agency has OK'd the de novo application for Viz.AI Contact, a software tool to help detect early signs of strokes.

US FDA has approved a software tool that analyzes images to warn clinicians early on when patients are at risk for strokes. The Viz.AIContact application, from the firm Viz.AI, is the first clinical decision support (CDS) software of its kind approved by FDA, and it comes at a time when the agency is working to update its policies for medical software products.

"The software device could benefit patients by notifying a specialist earlier [of a potential stroke], thereby decreasing the time to...

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