Translated by Chia-Jung Lin
Edited by Elaine Chuang

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Under the Medical Devices Act, which now allows schools to apply for medical device permits, National Yang Ming Chiao Tung University (NYCU) has obtained official approval from the Ministry of Health and Welfare for two medical devices developed in-house: an isokinetic measurement system and an AI-assisted brain tumor detection system. This achievement is expected to significantly reduce the cost of clinical treatment.

NYCU Receives Approval for In-House Medical Devices: Isokinetic Measurement and AI Brain Tumor Detection

In the past, physicians had to review images and annotate brain tumors manually. With the assistance of AI, the new system can automatically interpret and annotate magnetic resonance imaging (MRI) scans for three major types of brain tumors: acoustic neuromas, meningiomas, and brain metastases. This marks the first instance in Taiwan of intelligent medical software capable of automatically detecting and annotating multiple brain tumor types. 

Professor Yu-Te Wu, who led the development of the AI brain tumor detection technology at the Institute of Biophotonics, noted that prior to radiation therapy, doctors usually had to assess tumor volume, location, the presence of edema, and other pathological features using a large amount of image data.

The AI system was trained on over 200,000 2D images from Taipei Veterans General Hospital and Taichung Veterans General Hospital to overcome challenges such as variations in MRI image orientations, resolutions, tumor types, and sizes. This allows artificial intelligence to accurately interpret brain tumors.

The isokinetic measurement system is designed for children and elderly individuals who require lip muscle strength rehabilitation. It provides an effective method for lip muscle strength training.

The approval of these two medical devices by the Ministry of Health and Welfare is a significant step toward the commercialization of medical equipment. Professor Chun-Li Lin, Director of NYCU's Medical Device Innovation and Translation Center, emphasized that universities have traditionally been at the forefront of medical device design and development. However, prior to the relaxation of regulations, only companies could apply for inspection and registration, which affected the timeline for commercialization. 

The regulatory changes now allow universities to not only engage in research and development but also act as medical device manufacturers, facilitating the transformation of more research outcomes into commercial products and advancing the goal of clinical application.

NYCU has become the first university to hold QMS certification and medical device permits

In fact, the Medical Device Innovation and Translation Center at NYCU received approval for its 3D-printed mandibular plates in April of this year through the Taiwan Food and Drug Administration's Quality Management System (QMS). NYCU has become the first university to hold both QMS certification and first- and second-level medical device permits.

To enhance the quality of medical device research and development at universities and create value for the private sector, NYCU will focus on medical software and auxiliary medical devices. They will provide coordinated services, including clinical verification, regulatory compliance, quality assurance, and commercialization support, to accelerate medical device development, establish various QMS systems for different product types, and obtain inspection and registration, ultimately driving the commercialization of more research outcomes and advancing the goal of clinical application.