RapidAI Receives First and Only FDA 510(k) Clearance of Non-Contrast CT Imaging Product to Accelerate Acute Stroke Triage

Part of RapidAI’s industry-leading stroke solution, Rapid NCCT Stroke supports faster treatment and transfer decisions while driving greater equity of care

RapidAI, the global leader in neurovascular and vascular AI-enhanced clinical decision support and patient workflow, announced it has received FDA 510(k) clearance for Rapid NCCT Stroke – a major addition to the RapidAI suite of non-contrast based solutions for stroke and trauma care, and the first and only FDA cleared medical device to detect suspected intracranial hemorrhage (ICH) and large vessel occlusion (LVO) from value-based CT imaging.

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Rapid NCCT Stroke uses artificial intelligence to analyze non-contrast CT (NCCT) images to determine suspicion of ICH and LVO of the distal internal carotid artery (ICA) and middle cerebral artery (MCA-M1). The fully automated system then delivers triage and prioritization notifications through PACS, email, and the Rapid mobile app. Because NCCT imaging is readily available and is the initial imaging modality used for stroke and trauma patients, care teams can make time-sensitive workflow and transfer decisions faster. For hospitals that do advanced imaging, Rapid NCCT Stroke may significantly reduce the time between CT and CTA scans.

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Rapid NCCT Stroke supports teams in:

• Accelerating door-to-imaging and door-to-decision time
• Making faster transfer decisions
• Improving equity of care by giving centers of all levels greater access to advanced value-based CT imaging technology that may improve decision making and impact patient outcomes

“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,” said Karim Karti, CEO of RapidAI. “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.”

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