Heuron Achieves 'Korean First' with U.S. FDA Approval for Triage and Notification Solution

2024-05-21

Heuron Receives FDA 510(k) Clearance for 'Heuron ICH' as First Korean Solution for Triage and Notification




Heuron, a medical AI startup focused on neurological disorders based in South Korea, has achieved a significant milestone by obtaining pre-market approval (510(k) clearance) from the U.S. Food and Drug Administration (FDA) for its non-contrast CT imaging analysis solution, 'Heuron ICH.' This marks the first Korean neurological disorder solution to receive FDA approval specifically for triage and notification purposes.

 

Heuron ICH is an advanced AI solution that automates the triage and notification process for suspected intracranial hemorrhage (ICH) using only non-contrast CT scans. The solution is designed to quickly identify even very small hemorrhages that may be difficult for human eyes to detect, thereby aiding in the prompt assessment and treatment of emergency stroke patients. Notably, Heuron ICH boasts a sensitivity of 86% and specificity of 88%.

 

This approval marks the fifth FDA-cleared solution from Heuron, following Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Veuron-Brain-pAb3. Heuron continues to expand its global footprint, holding 15 Korean medical device approvals, 4 European CE (MDD), and numerous other international certifications.

 

Dr. Donghoon Shin, CEO of Heuron, stated, "This FDA approval is a significant boost for Heuron's expansion into the U.S. market. We are committed to continuing our efforts to register more medical solutions with the FDA and ensure that our diverse range of solutions provides valuable support to emergency patients in clinical settings across the U.S."

 

Additionally, Heuron ICH successfully met the FDA’s performance targets through clinical trials conducted last year in collaboration with Mass General Brigham, affiliated with Harvard Medical School.