Heuron, a brain and neurological disorders-focused startup, has received the US Food and Drug Administration (FDA) 510(k) clearance for Heuron ICH, a stroke triage and notification solution.

Heuron ICH is an advanced artificial intelligence (AI)-based non-contrast computed tomography (CT) imaging analysis solution.

The South Korean firm designed the brain disorder analysis solution to automatically screen and flag potential cases of intracranial haemorrhage using non-contrast CT images.  

According to Heuron, its regulatory milestone represents the first FDA approval of an AI-based solution from Korea, tailored for computer-aided triage and notification devices (CADt).

The primary objective of the solution is to promptly identify emergency brain haemorrhages that need immediate attention. This also includes detecting the minutest haemorrhages that are otherwise difficult to detect.

Heuron claimed that Heuron ICH has an 86% sensitivity and an 88% specificity, ensuring dependable and precise assistance in critical medical settings.

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.”

Heuron ICH is now the fifth solution from Heuron to get FDA approval after Veuron-Brain-mN1, Veuron-Brain-pAb, Heuron Beta Amyloid, and Veuron-Brain-pAb3.

Presently, the Korean firm has 15 domestic medical device approvals/certifications and four European CE (MDD) certifications along with various other global certifications.

Furthermore, Heuron ICH met the performance levels mandated by the FDA following clinical studies conducted last year in partnership with Mass General Brigham, an affiliate of Harvard Medical School.

Established in 2017, Heuron develops AI innovations for neurodegenerative illnesses and urgent stroke intervention.

The company facilitates accurate diagnosis of diseases such as Alzheimer’s and Parkinson’s disease using advanced software.

Recently, the startup signed a research collaboration with Singapore’s National University Hospital (NUH) to test Heuron AD and Heuron Brain PET for screening and predicting Alzheimer’s disease.