Harrison.ai Secures the US FDA 510(k) Clearance for Acute Infarct Triage on Non-Contrast CT Brain

Shots:

• The US FDA has granted 510(k) clearance to Harrison.ai’s acute infarct triage for non-contrast CT brain scans
• 510(k) submission compared infarct triage with existing stroke AI tools, incl. an FDA-cleared LVO device on non-contrast CT showing 63.5% sensitivity & 95.1% specificity for vessel occlusion detection only, plus CTA-based LVO systems that require contrast & only detect vessel occlusion
• On the other hand, the triage demonstrated ~89.2% sensitivity on thin CT slices & 85.7% on thick slices, with >80% sensitivity & specificity across all six vascular territories & mechanisms of infarct

Ref: Businesswire   |   Image: Harrison.ai   |   Press Release

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