Heuron Secures PMDA Approval for Stroke Analysis Solution, Accelerates Entry into Japanese Market

Nov. 2025

Heuron Secures PMDA Approval for Stroke Analysis Solution, Accelerates Entry into Japanese Market


- AI-powered stroke analysis solution obtains Japan medical device approval

- Revenue expected through partnership with DoctorNET


Heuron CTS(JP).png


Heuron Co.,, Ltd., a medical artificial intelligence (AI) company specializing in neurodegenerative and cerebrovascular diseases, announced that its stroke analysis AI solution, Heuron CTS (also known as Heuron StroCare Suite™), has received medical device sales approval from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA). With this approval, Heuron has officially entered the Japanese medical AI market, laying a foundation for expanded overseas revenue.


Heuron CTS is an emergency stroke triage AI solution based on non-contrast CT imaging. By automatically analyzing hyperdense and hypodense regions in CT scans, the solution supports clinicians in making rapid initial assessments—an essential capability in emergency settings. Japan has the world’s highest adoption rate of CT scanners, further increasing the solution’s market potential.


In February this year, Heuron signed a distribution agreement in Tokyo with DoctorNET, Japan’s largest teleradiology company. DoctorNET operates remote diagnostic imaging services and cloud-based medical data systems. After evaluating the technical capabilities of multiple AI vendors, DoctorNET selected Heuron as its preferred partner for AI solution integration.


Beginning in 2026, Heuron expects to generate full-scale revenue in Japan. This includes direct usage of the Heuron solution on DoctorNET’s teleradiology platform, which is used by more than 1,000 physicians and healthcare institutions. DoctorNET also plans to leverage its extensive customer network to drive additional hospital adoption. In parallel, Heuron is conducting clinical research at leading municipal medical centers to validate product utility and support market expansion.


Building on Heuron CTS, the company plans to accelerate PMDA approval and market launch of its dementia and Parkinson’s disease analysis solutions. As Japan faces a super-aging society, demand for diagnostic tools addressing both stroke and degenerative brain disorders continues to grow rapidly.


“Our PMDA approval marks the first major step in our entry into the Japanese market,” said Donghoon Shin, CEO of Heuron. “We aim to position Japan as a key hub for global revenue expansion.” He added, “We will also focus on securing approval and commercialization of our dementia and Parkinson’s solutions, with the goal of establishing Japan as one of our main export markets by 2026.”

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