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# FDA Clears RapidAI Intracranial Hemorrhage Triage Device
- URL: https://www.fdaweb.com/fda-clears-rapidai-intracranial-hemorrhage-triage-device/
- Published: 2022-11-23T12:00:00.000Z
- Updated: 2026-09-14T18:07:29.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153261

FDA has cleared a RapidAI 510(k) for the latest release of Rapid ICH, an intracranial hemorrhage triage and notification device with what the company says is a sensitivity of 97% and specificity of 100%. “While [Rapid ICH](https://www.rapidai.com/rapid-ich-hyperdensity?ref=fdaweb.com) uses artificial intelligence to quickly analyze non-contrast CT scans and notify clinicians of possible hemorrhage, [Rapid Hyperdensity](https://www.rapidai.com/rapid-ich-hyperdensity?ref=fdaweb.com) then provides physicians with a more refined view by automatically quantifying and characterizing tissue to identify the location and volume of hyperdense regions,” the company says. The latest device release eliminates false positives and gives physicians a high degree of confidence to make critical decisions about patients with acute brain hemorrhages, it adds.