【News】Applied for marketing authorization of HAL® for Medical Use (Lower Limb Type) as a new medical device in Japan

Today, on March 25, 2015, CYBERDYNE Inc. applied for marketing authorization of HAL® for Medical Use (Lower Limb Type) as a new medical device for orphan neural-muscular diseases, such as muscular dystrophy, amyotrophic lateral sclerosis (“ALS”) and so on under Japan’s Pharmaceutical and Medical Device Law (“PMDL”). New medical devices under the law should have different mechanisms, directions for use, efficacies or effects from those of existing medical devices. Applications for new medical devices require attachment of clinical test results.