PurpleAI Logo

Hyper Insight™ – ICH

Hyper Insight™ Stroke AI

One platform across the stroke pathway — hemorrhage, infarction, aneurysm, perfusion and 3D vascular imaging, on CT and MR. One solution is FDA-cleared today; seven more are in the FDA process. Select any solution for its description, capabilities, and performance evidence.

Hyper Insight™ – ICH

e-Label QRScan / Clicke-Label
NCCTLaunchedFDA 510(k) cleared

Triages suspected brain hemorrhage within seconds on non-contrast CT and alerts clinicians to potential findings.

Capabilities
  • Worklist prioritization
  • Mobile notifications
  • Instant specialist notification — auto alerts for suspected ICH
  • Seamless team collaboration — smart messaging & invitations
  • Mobile DICOM viewer — access anytime, anywhere
NCCTICH Binary TriageMobile Alert & DICOM Viewer
ICH 1Click to zoom
Performance & evidence

US pivotal — patient-wise. 13 US clinical sites · AUC 0.9864 · Sensitivity 95.45% · Specificity 98.47% · PPV 98.44% · NPV 95.54% · Mean processing time 16.39 ± 5.46 seconds · Subtype performance 94.7%–100%. The trial included diverse racial demographics (Alaskan Native, Asian, Black, White and others).

What it means clinically
  • The only ICH AI with dual regulatory clearance (FDA + MFDS), a NECA innovative technology designation, peer-reviewed external validation across 49,841 patients published in npj Digital Medicine, a 16.39-second mean processing time, and proven reader performance improvement — across subtypes, volumes and scanner families.
  • Reduces the performance gap for non-specialist physicians in under-resourced settings by +3.43% sensitivity.
  • Independently validated best-in-class ICH triage: #1 among four Korean-developed (two also FDA-cleared) ICH solutions on every confirmatory and calibration metric (AUPRC 0.97, precision 0.98); roughly 2% of alerts are false versus about 1 in 3 for comparators.
  • Independently validated workflow improvement: hemorrhage read ~5× earlier (median reading order 7.25→1.5), early diagnosis 49%→76%, with reader accuracy, sensitivity and specificity statistically unchanged.
  • Sensitivity 98.1% for the 1 to <5 mL volume stratum and 90.0% for bleeds under 1 mL — every volume stratum above 90%.