Heuron, Secures Medical AI Approvals in Malaysia and Singapore Consecutively

2026-09-18

Heuron, a medical AI company specializing in neurological diseases, announced on the 17th that it has successively secured medical device approvals for its major products in Malaysia and Singapore.


Heuron’s stroke diagnosis support AI software, "Heuron StroCare Suite™ (Heuron SCS)," received medical device approval from the Malaysian Ministry of Health (MDA). This solution automatically analyzes brain CT images using AI to rapidly identify stroke-related abnormalities and assists medical professionals in diagnosis and treatment decision-making.


Previously, Heuron obtained Class 3 approvals from the Korean Ministry of Food and Drug Safety (MFDS) for three non-contrast computed tomography (CT)-based stroke diagnosis solutions: Heuron ELVO, Heuron ICH, and Heuron ASPECTS.

In Singapore, the company secured additional approval for "Heuron AD" from the Health Sciences Authority (HSA). "Heuron AD" automatically analyzes brain MRI images to quantify the degree of atrophy in key brain regions, assisting in the analysis of degenerative brain diseases, including Alzheimer's disease. Following its existing Parkinson's disease diagnosis support solution, "Heuron IPD," the approval of "Heuron AD" expands Heuron’s neurodegenerative disease AI product lineup in Singapore to encompass both Parkinson's and Alzheimer's diseases.


On January 12, 2026, Heuron established a joint venture, "Heuron Global," in Bangkok, Thailand. Heuron Global currently conducts business across Asia, including Singapore, Vietnam, Indonesia, Malaysia, and India.


Shin Dong-hoon, CEO of Heuron, stated, "The approvals in Malaysia and Singapore are a crucial foundation for expanding Heuron’s stroke and neurodegenerative disease AI product lines into major Asian medical markets." He added, "Moving forward, we will center our efforts around Heuron Global to link country-specific approvals with local partnerships, expand adoption in actual clinical settings, and translate our Asian business into full-scale overseas revenue growth."