Powered by artificial intelligence (AI), the Rapid NCCT Stroke modality is reportedly the first medical device to gain FDA 510(k) clearance for detecting suspected large vessel occlusion and intracranial hemorrhage based on assessment of non-contrast computed tomography (NCCT).
The Food and Drug Administration (FDA) has granted 510(k) clearance for Rapid NCCT Stroke (RapidAI), which utilizes artificial intelligence (AI) to assess non-contrast computed tomography (NCCT) scans for possible intracranial hemorrhage (ICH) and large vessel occlusion (LVO).
If there is suspicion of ICH or LVO on head CT scans, RapidAI said the Rapid NCCT Stroke modality sends automated triage and prioritization notifications via PACS, email and the RapidAI mobile app.
By flagging suspicious findings in reportedly less than three minutes on non-contrast CT, the initial imaging utilized for stroke and trauma patients, Rapid NCCT Stroke reduces potential delays between initial CT and computed tomography angiography (CTA), according to RapidAI. The company said this enables earlier time-sensitive workflow adjustments and faster transfer decisions when necessary.
Image courtesy of RapidAI.
“This technology will not only have an enormous impact on stroke care here in the (United States) 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,” noted Karim Karti, the chief executive officer 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.”
(Editor’s note: For related content, see “FDA Clears Adjunctive AI for Non-Contrast CT of Brain Injuries and Hemorrhages” and “Annalise.ai Obtains Seven New AI FDA 510(k) Clearances for Head CT and Chest X-Ray.”)
Study: AI-Generated ADC Maps from MRI More Than Double Specificity in Prostate Cancer Detection
June 5th 2025Emerging research showed that AI-generated ADC mapping from MRI led to significant increases in accuracy, PPV and specificity in comparison to conventional ADC mapping while achieving a 93 percent sensitivity for PCa.
Can AI Assessment of PET Imaging Predict Treatment Outcomes for Patients with Lymphoma?
June 2nd 2025The use of adjunctive AI software with pre-treatment PET imaging demonstrated over a fourfold higher likelihood of predicting progression-free survival (PFS) in patients being treated for lymphoma, according to a new meta-analysis.
Lunit Unveils Enhanced AI-Powered CXR Software Update
May 28th 2025The Lunit Insight CXR4 update reportedly offers new features such as current-prior comparison of chest X-rays (CXRs), acute bone fracture detection and a 99.5 percent negative predictive value (NPV) for identifying normal CXRs.