South Korean medical AI startup Heuron has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its Heuron ICH solution, a non-contrast CT imaging analysis tool for intracranial haemorrhage.

This approval marks the first for a Korean AI-based brain disorder analysis solution in the field of computer-aided triage and notification devices (CADt).

Heuron ICH is designed to automatically detect potential intracranial haemorrhage cases using non-contrast CT images. It aims to quickly identify emergency brain haemorrhages, with a reported sensitivity of 86% and specificity of 88%.

The advanced AI solution is particularly adept at detecting small haemorrhages that may be missed by human eyes.

Heuron’s success with the FDA was bolstered by clinical trials conducted in partnership with Mass General Brigham, a Harvard Medical School affiliate.

These trials were instrumental in demonstrating the performance levels required for FDA approval.

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Heuron CEO Donghoon Shin said: “Securing this product approval marks a significant milestone, facilitating our swift penetration into the US market. Our commitment extends beyond this achievement as we endeavour to expand our portfolio of FDA-approved medical solutions.

“We are dedicated to optimising the utilisation of Heuron’s diverse offerings within US clinical environments, particularly for emergency patient care.”

This FDA clearance is the fifth for Heuron, adding to its portfolio of approved solutions, including Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Veuron-Brain-pAb3.

Heuron also holds four European CE (MDD) certifications, 15 domestic medical device approvals, and other international certifications.

Founded in 2017, Heuron is engaged in developing medical AI solutions for neurodegenerative diseases and emergency stroke care.

The company’s StroCare Suite software suite assists in the accurate diagnosis of Alzheimer’s and Parkinson’s diseases and expedites stroke treatment.