FDA Clears Brainomix 360 Hyperdensity AI Tool for CT Stroke Detection

FDA 510(k) clearance granted to Brainomix 360 Hyperdensity, an AI-based software for detecting hyperdense vessel signs on CT — a key early marker of large-vessel occlusion stroke. Product code QIH.

• 510(k) clearance (K260406) for Brainomix Limited's 360 Hyperdensity, a radiological computer-aided detection software targeting hyperdense artery signs on non-contrast CT in suspected acute stroke.
• Classified under FDA product code QIH (radiology devices); fits within Brainomix's broader 360 stroke imaging platform alongside existing e-ASPECTS and e-CTA tools.
• No clinical performance numbers (sensitivity/specificity, AUC) are reported in the clearance summary; post-market real-world data will be needed to benchmark accuracy against radiologist reads.

RadPigeon summaries are original and for information only. They are not clinical advice.