Summary: Heuron, a South Korean medical AI startup, announces that its non-contrast CT imaging analysis solution, Heuron ICH, has received U.S. FDA 510(k) clearance, marking the first FDA approval of an AI-based brain disorder analysis solution from Korea.

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Heuron, a medical AI startup focused on brain and neurological disorders based in South Korea, announces that its non-contrast CT imaging analysis solution, Heuron ICH, has received U.S. FDA 510(k) clearance. This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea for computer-aided triage and notification devices (CADt).

Intracranial Hemorrhage Detection

Heuron ICH is an AI technology that screens for intracranial hemorrhages using non-contrast CT images, detecting even small hemorrhages with 86% sensitivity and 88% specificity. It is the fifth Heuron solution to receive FDA clearance, following Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Veuron-Brain-pAb3. Heuron holds 15 domestic medical device approvals, four European CE (MDD) certifications, and various other international certifications.

Enhance U.S. Clinical Care

“Securing this product approval marks a significant milestone, facilitating our swift penetration into the U.S. market,” says Heuron CEO Donghoon Shin. “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.”

Additionally, Heuron ICH successfully achieved the performance levels required by the FDA through clinical trials conducted last year in collaboration with Mass General Brigham, affiliated with Harvard Medical School.