FDA grants 510(k) clearance to CT imaging analysis solution for intracerebral hemorrhage

The FDA has granted 510(k) clearance to a South Korea-based specialized medical AI startup for its non-contrast CT imaging analysis solution to detect intracerebral hemorrhage.

According to a press release from Heuron Co. Ltd., the clearance marks the first FDA approval of an AI-based brain disorder analysis solution from Korea for computer-aided triage and notification devices.

Heuron ICH is designed to automatically screen and signal potential cases of intracranial hemorrhage by relying solely on non-contrast CT images. Its primary function is to swiftly discern emergency brain hemorrhages that require immediate attention in a significantly detailed manner which allows for detection of smaller hemorrhages that may go unnoticed by the naked eye.

According to statistics cited in the company release, Heuron ICH has recorded a sensitivity of 86% and specificity of 88%, ensuring reliable and accurate assistance during medical emergencies involving stroke.

“Securing this product approval marks a significant milestone, facilitating our swift penetration into the U.S. market,” Heuron CEO Donghoon Shin said in the release. “We are dedicated to optimizing the utilization of Heuron's diverse offerings within U.S. clinical environments, particularly for emergency patient care."