Hyper Insight™ - ICH*

AI-powered diagnostic support for rapid, accurate detection and localization of brain hemorrhages on non-contrast CT, with ROI visualization and volume quantification to help radiologists assess hemorrhagic regions.

WORKLIST

Worklist Prioritization & Golden Time Advantage

VIEWER

AI-Driven Analysis

REPORT

Intuitive Reporting

MOBILE

Notifications & AI DICOM Viewer

US CLINICAL VALIDATION

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A multi-center, randomized, retrospective crossover superiority pivotal study, demonstrating high performance across all major ICH subtypes.

Performance Metrics

Metric	Performance Result (Patient-wise)
Centers	13 US clinical sites
Trial Size	394 brain CT images (198 positive / 196 negative cases)
AUC	98.64%
Sensitivity	95.45%
Specificity	98.47%
Speed (Notification Seconds)	Average time was 16.39 ± 5.46 seconds
Subtype Performance	94.7%~100%
Data Diversity	The trial included diverse racial demographics (Alaskan Native, Asian, Black, White, etc.)

npj Digital Medicine (2023)

Deep learning based automatic detection algorithm for acute intracranial haemorrhage: a pivotal randomized clinical trial

Comparison vs. Peers

Device	Sensitivity	Specificity	AUC	Speed (seconds)	Sensitivity for Subtypes
Hyper Insight-ICH	95.5 (#3)	98.5 (#2)	0.9864 (#1)	16.4 (#2)	IPH 97.3, IVH 97.67, SAH 97.65, SDH 94.69, EDH 100
Company A	95	96	0.97	29.4	IPH 96, IVH 100, SAH 86, SDH 93, EDH 100
Company B	96.8	99.8	0.9863	39	IPH 100, IVH 100, SAH 100, SDH 89.5
Company C	94.8	92.5	0.9367	22.2	N/A
Company D	89.2	91.4	N/A	50-126	IPH 96.6, IVH 100, SAH 35.7, SDH 66.7
Company E	90.6	93.1	N/A	43	N/A
Company F	94.7	94.9	0.983	35	N/A
Company G	97	93	N/A	77	N/A
Company H	95	93.1	N/A	13.3	SAH 86.1
Company I	92	95	N/A	41.1	N/A

Hyper Insight-ICH

Sensitivity:95.5 (#3)

Specificity:98.5 (#2)

AUC:0.9864 (#1)

Speed (seconds):16.4 (#2)

Subtypes: IPH 97.3, IVH 97.67, SAH 97.65, SDH 94.69, EDH 100

Company A

Sensitivity:95

Specificity:96

AUC:0.97

Speed (seconds):29.4

Subtypes: IPH 96, IVH 100, SAH 86, SDH 93, EDH 100

Company B

Sensitivity:96.8

Specificity:99.8

AUC:0.9863

Speed (seconds):39

Subtypes: IPH 100, IVH 100, SAH 100, SDH 89.5

Company C

Sensitivity:94.8

Specificity:92.5

AUC:0.9367

Speed (seconds):22.2

Subtypes: N/A

Company D

Sensitivity:89.2

Specificity:91.4

AUC:N/A

Speed (seconds):50-126

Subtypes: IPH 96.6, IVH 100, SAH 35.7, SDH 66.7

Company E

Sensitivity:90.6

Specificity:93.1

AUC:N/A

Speed (seconds):43

Subtypes: N/A

Company F

Sensitivity:94.7

Specificity:94.9

AUC:0.983

Speed (seconds):35

Subtypes: N/A

Company G

Sensitivity:97

Specificity:93

AUC:N/A

Speed (seconds):77

Subtypes: N/A

Company H

Sensitivity:95

Specificity:93.1

AUC:N/A

Speed (seconds):13.3

Subtypes: SAH 86.1

Company I

Sensitivity:92

Specificity:95

AUC:N/A

Speed (seconds):41.1

Subtypes: N/A

Based on internal analysis using FDA database and other reliable sources

*
As a Radiological Computer Aided Triage And Notification Software, Hyper Insight™ – ICH functions as a triage and notification tool – supporting, not replacing, medical judgment. Final diagnosis and treatment decisions remain the responsibility of qualified medical professionals.
*
Certain features or modules described here are not cleared or approved by the US Food and Drug Administration (FDA) and are not intended for clinical use in the United States. These features are provided for research, evaluation, and educational purposes only.