【News】Completion of the implementation stage of the physician-led clinical trial of Robot Suit HAL for Medical Use

CYBERDYNE (hereinafter the Company) was informed that the physician-led clinical trial in Japan of our Robot Suit HAL for Medical Use (NCY-3001 test) had completed its processes for all subjects on August 8, 2014, including the follow-up review.

The coordinating investigator, Dr. Takashi Nakajima (Deputy Director of National Hospital Organization Niigata National Hospital),  will analyze the data and prepare a summary documentation of the trial. Based on the documentation, the Company will file a pharmaceutical application for the Robot Suit HAL for Medical Use aiming for a manufacturing and distribution license as a medical device in Japan.

In June 2013, Robot Suit HAL for Medical Use obtained conformity certification as the world’s first robotic therapeutic device concerning the Medical Device Directive in the EU (MDD) and also achieved CE Marking 0197 in the EU region. 

cf.) Progress report by Center for Clinical Trials, Japan Medical Association
https://dbcentre3.jmacct.med.or.jp/jmactr/App/JMACTRE02_04/JMACTRE02_04.aspx?kbn=3&seqno=3962