Smooth support for dizziness diagnosis! Eye movement testing equipment authenticated and commercialized as the first medical device program in the field of otorhinolaryngology

An idea by Professor Hiroshi Yamashita and Lecturer Makoto Hashimoto of Yamaguchi University Graduate School of Medicine has been authenticated for the first time in the field of otorhinolaryngology, following revision and enforcement of the Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices in 2014, and has become Japan's only computer software medical device program that can record rotatory nystagmus.

This medical device program has been commercialized as "yVOG glass," a piece of eye movement testing equipment for diagnosing dizziness that is categorized as a controlled medical device (Class II), and is currently being prepared to go on sale. This equipment consists of a head position sensor, Frenzel glasses that capture eye movements, and analysis software. The equipment analyzes images of head movements and eye movements in terms of horizontal, vertical and rotational movements, and helps doctors make a diagnosis by indicating whether the movements correspond to nystagmus. The program for the eye movement testing equipment will also be available on its own as the program medical device "yVOG" (Medical Device Approval Number: 228AFBZX00141000).

Until now, diagnosis of dizziness has relied heavily on the doctor's level of experience. However, as it will make quantitative data available through smooth operation that will be easy for doctors to use, there is tremendous anticipation about this equipment, and has already been picked up by more than 10 media organizations, including the Nikkei and the Nihon Ikakikai Shimbun.

"yVOG Glass" and "yVOG" represent the achievements of joint research and development by, in addition to Yamaguchi University, medical device manufacturing and sales company Daiichi Medical Co., Ltd. (Tokyo), image processing technology specialists YOODS Co., Ltd. (Yamaguchi City), and Takuo Ikeda, Head of the Department of Otorhinolaryngology at the Tsudumigaura Medical Center for Children with Disabilities (Shunan City). With support also from Yamaguchi Prefecture's "R & D Promotion Subsidy System ( Yamaguchi Prefecture Government )." and Yamaguchi Prefectural Industrial Technology Institute, the products were commercialized as a result of university-industry-government collaboration.

The details are also scheduled to be reported at the 118th Annual Meeting of the ORL Society of Japan, which will be held in Hiroshima City from May 17 (Wed.) to 20 (Sat.), 2017.