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.