FDA Clears AI Advance for Detecting Intracranial Hemorrhage on Non-Contrast CT

The Food and Drug Administration (FDA) has granted 510(k) clearance for Heuron ICH, an artificial intelligence (AI)-enabled software that may facilitate timely detection and triage of intracranial hemorrhages.

Through interpretation of non-contrast computed tomography (CT) scans, Heuron ICH offers an 86 percent sensitivity rate and an 88 percent specificity rate for intracranial hemorrhage, according to Heuron, the developer of Heuron ICH.

Heuron maintained that Heuron ICH facilitates rapid detection of intracranial hemorrhages and can diagnose minute hemorrhages that may evade radiologist detection.

The company noted that Heuron ICH is Heuron’s fifth AI software to garner FDA clearance.

"Securing this product approval marks a significant milestone, facilitating our swift penetration into the U.S. market,” noted Donghoon Shin, the CEO of Heuron. “Our commitment extends beyond this achievement as we endeavor to expand our portfolio of FDA-approved medical solutions. We are dedicated to optimizing the utilization of Heuron's diverse offerings within U.S. clinical environments, particularly for emergency patient care."