The US Food and Drug Administration (FDA) has granted 510(k) clearance to RapidAI’s non-contrast computerised tomography (CT) imaging solution to accelerate acute stroke triage.
Rapid NCCT (non-contrast CT) Stroke is claimed to be the first and only medical device approved by the FDA for the identification of suspected intracranial haemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.
The fully automated device leverages artificial intelligence (AI) to analyse NCCT images to detect ICH and LVO in the distal internal carotid artery and middle cerebral artery.
The system sends notifications related to triage and prioritisation through picture archiving and communication systems (PACS), email and the Rapid mobile app.
RapidAI CEO Karim Karti said: “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 centres.
“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.”
Rapid NCCT Stroke helps speed up door-to-imaging and door-to-decision time.
The system enables centres to access advanced value-based CT imaging technology for enhanced decision-making and patient outcomes.
NCCT imaging is the first-line imaging tool used for stroke and trauma patients and improved systems can facilitate faster transfer decisions.
RapidAI offers neurovascular and vascular clinical decision support and patient workflow solutions using AI.