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NCKU Tops Taiwan Universities With Medical R&D Innovation Abdominal Muscle Groups Analysis Software Approved As Class 2 Software as Medical Device (SaMD) by TFDA

Written by Mingchun Wu. Image credit to NCKU News Center
The “Abdominal Muscle Groups Analysis Software”, developed by the Medical Imaging Department in NCKU Hospital, is approved as class II software as medical device by TFDA. The license ceremony on August 15 was attended by NCKU President Meng-Ru Shen (沈孟儒) and witnessed by Tsung-Tsong Wu (吳政忠), the Minister of the Executive Yuan Minister and Naitonal Science and Technology Council, and Hwei-Fang Cheng (陳惠芳), the Deputy Director of TFDA.
成功大學繼 2022 年領先全國大專校院,獲得醫療器材製造商及販賣商許可證,今(2023)年再次於大專院校界拔得頭籌,以跨領域人工智慧醫療研發成果─「"成功大學" 腹部電腦斷層身體組成定量系統」軟體取得衛生福利部食品藥物管理署「第二等級醫療器材許可證」
TFDA approved the NCKU Abdominal Muscle Groups Analysis Software as class II medical device
“The medical device industry has been greatly benefited by the TFDA streamlined registration process and NCKU’s enhanced R&D capability in Artificial Intelligence (AI), medical device and hospital data management, “noted Minister Wu.
“NCKU Abdominal muscle groups analysis software will be applied in the Computed Tomography (CT) diagnosis for Sarcopenia, a common syndrome among the elderly and particularly for cancer patients, “ noted Dr. Yi-Shan Tsai (蔡依珊), the director of NCKU Clinical Innovation and Research Center (CIC). “This new software will enable the medical teams to, effectively and efficiently, diagnose and monitor the muscle health of body composition, in order to advise an appropriate nutrition support program for muscle recovery, which is a critical factor for the prognosis improvement and survival rate of cancer patients.”
「"成功大學" 腹部電腦斷層身體組成定量系統」軟體,讓病友了解肌肉健康,做為後續追蹤比較及加強營養提升
NCKU Abdominal muscle groups analysis software will be applied in the Computed Tomography (CT) diagnosis for Sarcopenia
A significant time efficiency has been achieved with this new software - it only takes seconds to produce all the medical images required for diagnosis. Comparatively, the traditional commercial system, SliceOmatic, will need 20 minutes to produce just one single image.
With this new software, the CIC in NCKU Hospital now launches a new project, quantification of the body composition by computed tomography in health population retrieved from the NCKU Hospital Academic Research Database (CARD), to facilitate future researches for normative reference values of the skeletal muscle index (SMI) derived from core muscle area.
“NCKU aims to make the AI application in healthcare more affordable for hospitals. The collaboration for this new software, with R&D innovation emerged in CIC and FDA application process advised by the NCKU Medical Device Innovation Center, has been a great success,” said President Shen. “We are committed to the R&D capability development for medical services and healthcare, and will continue to contribute to the society and create the values, to achieve the social responsibility of NCKU College of Medicine and university hospital.”  
Provider: NCKU News Center
Date: 2023-08-18
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