First Approval of a Robotic Suit as a Medical Device

On 10 November 2015 the Medical Equipment and External Diagnosis Subcommittee of the MHLW's Pharmaceutical Affairs and Food Sanitation Council approved a robotic exoskeleton developed by the company Cyberdyne to assist physically challenged people. It was mainly developed as a new medical device for orphan neural-muscular diseases. After being designated as orphan medical device by the MHLW in December 2014, thus becoming subject to priority review for marketing authorization and officially applying for it in March 2015, the Council's subcommittee finally gave its authorisation. For more information, please se the attachment.

Picture: ASIMO walking stairs
Copyright: Wikipedia in the public domain


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