After taking the lead among tertiary institutions for the approval of sales and design manufacturing of medical devices last year, National Cheng Kung University (NCKU) has become the first R&D institute to obtain a Class II medical device clearance from Taiwan's FDA this year for its cross-disciplinary artificial intelligence healthcare research and development achievement, namely the "iMbody" system. 

With the assistance of NCKU's Medical Device Innovation Center (MDIC), this abdominal computed tomography body composition quantification system software of NCKU was approved by TFDA in June. In order to expand the distribution channels of smart medical devices, a Cheng Kung University spin-off company, MegaPro Bio, has been established and has obtained a licence for the sale of medical devices and a design and manufacturing license. The software has been granted four patents for inventions, and is in the process of applying for twelve patents in Taiwan, the U.S., Europe, Japan, and Korea. The software is scheduled to apply for the Quality Management System (QMS) for domestic medical device manufacturers by the end of this year.