Clinical Evidence
Claims are easy. Evidence is on the record.
NeuroICH, the intracranial hemorrhage detection module of the AI Suite, is an FDA 510(k) cleared (K241719) AI module that detects intracranial hemorrhage on non-contrast head CT in under 60 seconds, with 97.5% sensitivity and 90.3% accuracy. Cleared by the FDA on November 7, 2024. This page collects the regulatory record, the validated performance data, and the peer-reviewed work behind SaveLife.AI.
Validated performance
These figures come from the validation behind FDA review of K241719, not from internal marketing benchmarks.
Validation scope
- Multiple patient age groups and both genders
- Multiple CT scanner manufacturers, including Siemens and Philips
- Various slice thicknesses and acquisition protocols
- Hemorrhage subtype classification: IPH, IVH, SAH, SDH, EDH
- Per-type confidence scores and visual localization markers
The regulatory record
Every fact below is verifiable in the FDA 510(k) database. Read the primary sources, not just our summary of them.
Clearance status, module by module
Each clearance number belongs to its specific module and no other. We state review status plainly rather than implying the whole suite is cleared.
Peer-reviewed work
Selected publications from the SaveLife.AI clinical team, part of 27+ peer-reviewed publications, book chapters, and abstracts by Dr. Junaid Kalia, MD. The NeuroICH device validation itself is documented in the 510(k) record above.
Cureus · doi:10.7759/cureus.79506
OBM Neurobiology · doi:10.21926/obm.neurobiol.2401206
Frontiers in AI · doi:10.3389/frai.2022.962165
Cureus · doi:10.7759/cureus.31668
Frontiers in Neurology · doi:10.3389/fneur.2020.559322
Frontiers in Neurology · doi:10.3389/fneur.2016.00064
Neurology · doi:10.1212/wnl.0b013e31826992cf
HITRUST CSF Certified · HIPAA Compliant · Your clinical data is not training data. Review our compliance posture
See the evidence run in your workflow.
NeuroICH deploys inside RadioViewAI or through ConnectAI into your existing PACS and EHR, alerts in under 30 seconds included.