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Japan recognizes Cyberdyne’s robotic suit as medical device, widespread use anticipated


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Cyberdyne CEO Yoshiyuki Sankai speaks at a news conference at the health ministry on Wednesday, with the firm’s HAL robot suit on display. | KAZUAKI NAGATA

Cyberdyne Inc. said Wednesday its powered exoskeleton has received government approval as a medical device. It said it is first robotics device ever to secure such status in Japan.

“We have finally reached the stage … where technology born in Japan has become a medical device,” Yoshiyuki Sankai, founder and CEO of the Ibaraki-based robotics firm, told a news conference at the health ministry.


The health ministry said HAL has been approved as a medical device for diseases including spinal muscular atrophy and amyotrophic lateral sclerosis.

Cyberdyne’s Hybrid Assistive Limb, commonly known as HAL, has already won approval as a medical device in Europe.

HAL is a robotic suit for the lower body that helps mobility in users who are disabled or have limited muscle ability. It has potential applications among the elderly, for example.

Sankai said it is a big leap for Japan, which is facing the challenge of an aging society and will need innovative ideas and products to cope.

“I feel that a major reform is underway to create a new Japanese medical industry,” said Sankai, who is also a professor at the University of Tsukuba.

The product has been a long time in development. Sankai produced the first HAL prototype in 1997.

When people will their bodies to move, bioelectric signals generated in the brain travel a neural network to the muscles. HAL senses the signals and its motors immediately give added power to the wearer’s intended movement, such as standing up or walking.

There is a hope that if people who suffer from paralyzed limbs use HAL regularly their bodies might even regenerate damaged nerve networks, resulting in renewed ability.

Sankai said one significance of securing approval for HAL as a medical device is that it opens up possibilities for users to obtain it on their public health insurance.

Cyberdyne plans to submit a request to the health ministry to make this possible. Sankai said the process probably will take less than a year, but warned that it remains unclear what insured patients would have to pay out of their pockets to use HAL.


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