Industry first: FDA clears device for detecting stroke on noncontrast CT

The U.S. Food and Drug Administration has granted clearance for a new tool from artificial intelligence firm RapidAI to detect possible strokes on noncontrast CT.

The San Mateo, California, company said this represents the “first and only” device green-lit for pinpointing suspected intracranial hemorrhage and large vessel occlusion via imaging. RapidAI said the product will allow care teams to make critical decisions on triage and transfer faster, significantly reducing the time between scans and subsequent treatment.

RapidAI CEO Karim Karti said the technology aims to give smaller facilities access to tools that are often only available at comprehensive stroke centers.

“Our hope is that by providing better information early for more informed treatment and transfer decisions, Rapid NCCT Stroke will support faster stroke care and better patient outcomes,” he said in an April 18 announcement.

RapidAI said the automated software deploys artificial intelligence to analyze CT scans and determine stroke status. It can then deliver any notifications around triage via the PACS, email or mobile app.

Marty Stempniak

Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic. 

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