CYBERDYNE : Notice of medical device approval for small-size model of Medical HAL in Japan

CYBERDYNE Inc. (President & CEO: Yoshiyuki Sankai) has achieved a major milestone with the approval to manufacture and sell its small-size Medical HAL Lower Limb Type B in Japan. Granted by the Japanese Minister of Health, Labour and Welfare on January 31, 2025, this approval marks a significant step in expanding access to Cybernics Treatment for patients previously unable to undergo therapy due to size restrictions.

The application for the small-size Medical HAL was submitted in June 2023 to the Pharmaceuticals and Medical Devices Agency as a treatment device for designated conditions*¹. Now approved in Japan, the U.S., and Europe, this advanced robotic medical device is set to benefit patients between 100 cm and 150 cm in height, opening new possibilities for rehabilitation and mobility recovery.

With regulatory approval secured in the three largest global medical markets, CYBERDYNE is now preparing to apply for insurance coverage in Japan, ensuring broader accessibility. The company remains committed to accelerating the global expansion of its medical HAL business, reinforcing its mission to revolutionize rehabilitation and transform the future of medical technology.