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Cyberdyne’s Hybrid Assistive Limb (HAL) Gets FDA Approval

  • 26 January 2018
  • Sam Mire

There’s a decent chance that you’ve seen some form of exoskeleton helping those with neurological and other lower limb disabilities in their rehabilitation process. Now, one Japanese company has gained FDA approval for their exoskeleton device, which helps those with walking inhibitions strengthen the neural pathways that often cause a disconnect between the mental and physical pathways.

Cyberdyne is a Japanese robotics company, and 56-year-old CEO Yoshiyuki Sankai is the engineer behind the Hybrid Assistive Limb, otherwise known as HAL. Now, Cyberdyne has been granted permission by the U.S. Food and Drug Administration to offer the use of HAL technology through licensed medical administrators in the United States.

Details about HAL for Medical Use, the version of the exoskeleton that was given FDA approval, is flexible for suiting to different body types, and will work to help re-establish more normative walking ability in patients who suffer from traumatic spinal cord injury, Musculoskeletal Ambulation Disability Symptom Complex (MADS), traumatic brain injury, cerebrovascular diseases, diseases of the brain and neuromuscular system, and other conditions which are affected by neurological abnormalities.

A connected controller allows the user to dictate the exoskeleton’s functions, from starting and stopping assistance and several other settings. Still, HAL essentially works to strengthen the neural pathways that connect thought to action, in this case walking; processes that are often the primary cause of abnormalities in walking for those with certain medical conditions.

“The robot steps in between the cerebral nerve system and the muscles to help reconstruct a network loop (for the signals),” Sankai said. Though HAL for Medical Use has been available in Japan for years, breaking into the American medical field and gaining approval from the notoriously ham-handed FDA has been a challenge for Sankai. But Despite facing resistance, he has worked steadily to bring HAL to the market, and it appears he has cleared a major hurdle.

Of course, I visited large firms. I think I talked to nearly half of Japan’s top 20 firms. Presidents and management teams really praised my work, he said. One reason why I can keep going is simple. If this had been a project handed to me by someone else, I’m not sure I could have done it, but this is something that comes from within me.

About Sam Mire

Sam is a Market Research Analyst at Disruptor Daily. He's a trained journalist with experience in the field of disruptive technology. He’s versed in the impact that blockchain technology is having on industries of today, from healthcare to cannabis. He’s written extensively on the individuals and companies shaping the future of tech, working directly with many of them to advance their vision. Sam is known for writing work that brings value to industry professionals and the generally curious – as well as an occasional smile to the face.

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