JAPAN TIMES


Cyberdyne Inc. said Wednesday its robot suit has become the first robotics device in the country to receive government approval as a medical device.

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

In Europe, Cyberdyne’s Hybrid Assistive Limb, called HAL, has already been approved as a medical device.

HAL is a robotic suit for the lower body that helps disabled and senior citizens’ mobility.

Sankai said it is a big leap for Japan, which faces aging society issues and will need innovative ideas and products to cope with it.

“I feel that a major reform is in progress to create a new Japanese medical industry,” said Sankai, who is also a professor at the University of Tsukuba and made the first HAL prototype in 1997.

When people will their bodies to move, bioelectric signals generated in the brain travel a neural network in the spinal cord to muscles.

HAL picks up and understands such signals, and its motors immediately give added power to the wearer’s intended movement, such as standing and walking.

The hope is that if people who suffer from paralyzed limbs use HAL regularly, their bodies might regenerate damaged nerve networks, resulting in new or improved movement of their legs.
Sankai said one significance of getting approved as a medical device is that it opens up possibilities for people who need HAL to access it with 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 he said it is still unclear how much it will cost for patients to use he HAL with the help of their insurance.

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