Heuron's ‘Heuron StroCare Suite™’ Designated as Innovative Medical Technology by the MOHW

2024-03-11




Heuron, a medical AI startup focused on neurological disorders based in South Korea, has announced that its AI-based emergency stroke triage solution, ‘Heuron StroCare Suite,’ has been designated as an innovative medical technology by the Ministry of Health and Welfare’s integrated assessment for innovative medical devices.

 

According to the evaluation results published by the Ministry of Health and Welfare, ‘Heuron StroCare Suite’ will be utilized in clinical settings as an innovative medical technology with demonstrated safety and potential from June 1, 2024, to May 31, 2026. This designation is part of a system established by the Ministry of Health and Welfare and the NECA to promote the use of promising future technologies. It allows provisional market entry for technologies that prove their safety and efficacy, with formal registration following further validation.

 

‘Heuron StroCare Suite™’ is an AI solution that analyzes emergency large vessel occlusion using non-contrast CT images. It automatically analyzes brain CT images of acute stroke patients in the emergency room, screens for suspected large vessel occlusion, and provides alert services for priority interpretation by medical staff. By prioritizing the classification of large vessel occlusion patients, the solution aims to reduce treatment initiation times, facilitating faster treatment within the golden hour and improving stroke patient outcomes.

 

Heuron has secured provisional insurance coverage for its AI-based emergency stroke triage solution, ‘Heuron StroCare Suite,’ through its innovative medical technology evaluation. This provisional coverage will enable the solution to be supplied on a non-reimbursed basis over the next two years.

 

Dr. Donghoon Shin, CEO of Heuron, stated, “The designation of ‘Heuron StroCare Suite’ as an innovative medical technology acknowledges its significant role in improving the initial response to acute stroke patients by facilitating rapid diagnosis and reducing treatment times. We are optimistic that it will contribute to monetization through non-reimbursed supply and enhance the emergency stroke medical system.”

 

Additionally, to strengthen the clinical evidence for its innovative medical technology, Heuron has recently established an in-house Medical Affairs team, recruiting Dr. Ah-Rum Lee from the Department of Radiology at Soonchunhyang University Bucheon Hospital and Dr. Jae-Hong Heo from the Department of Emergency Medicine at Gyeonggi-do Medical Center Icheon Hospital.

 

Heuron plans to build robust clinical evidence related to stroke and recruit relevant specialists, with the goal of undergoing re-evaluation for innovative medical technology and pursuing formal health insurance registration in two years.