RapidAI’s Rapid NCCT Stroke Tool Gains FDA Nod

RapidAI, a developer of neurovascular artificial intelligence (AI)-enhanced clinical decision support and patient workflow tools, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for Rapid NCCT Stroke.
 
Rapid NCCT Stroke is a non-contrast based solution to spot suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging. According to RapidAI, it’s the first and only FDA-cleared device with this capability.
 
The tool uses AI to analyze non-contrast (NCCT) images to determine ICH and LVO suspicion of the distal internal carotid artery (ICA) and middle cerebral artery (MCA-M1). The system then delivers triage and prioritization notifications through PACS, email, and the Rapid mobile app.
 
NCCT imaging is the initial modality used for stroke and trauma patients. For hospitals that do advanced imaging, Rapid NCCT Stroke might significantly reduce time between CT and CTA scans.
 
“This technology will not only have an enormous impact on stroke care here in the U.S. but also globally, by giving care teams at small, local, or regional facilities around the world access to advanced clinical decision support technology too often only available at comprehensive stroke centers,” Karim Karti, CEO of RapidAI told the press. “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. This is an incredible achievement for the team and yet another example of RapidAI’s continued leadership in creating the next evolution of stroke care technology.”
 
Rapid NCCT Stroke also supports teams in boosting door-to-imaging and door-to-decision time, making faster transfer conditions, and improving equity of care.
 
RapidAI was granted FDA clearance for the Rapid ICH intracranial hemorrhage triage and notification tool in January.