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ReWalk FDA Approval: Exoskeleton for Paraplegics Gets the Green Light

Image: ReWalk FDA Approval: Exoskeleton for Paraplegics Gets the Green Light

By    |   Friday, 27 Jun 2014 10:50 AM

ReWalk, a robotic exoskeleton that helps paraplegics walk, is the nation's first such device to be approved by the FDA.

The company behind the wearable technology was given the green light after extensive performance testing and multiple clinical studies, it announced in a press release on Friday.

"This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries," said Larry Jasinski, CEO of ReWalk Robotics.

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"For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials."

The unit weighs about 7 pounds, and will be customized for each user to ensure the best fit possible for comfort, performance, and safety. It consists of a series of metal braces and motors that sort of resemble robotic pants and is powered by batteries stored in a backpack. Users control the device through their movements as well as a remote control attached to the wrist.

Thus far, it has been selling in Europe for roughly $72,000, but the company has yet to announce pricing for the U.S., according to Engadet.com.

The FDA has only approved the device for those with spinal cord injuries who can stand with assistance and use crutches. It is not approved for those suffering from unhealed fractures or other conditions that weaken the body, including infection, respiratory disease, etc.

"ReWalking is much more than walking," said Jeff Dykan, ReWalk's chairman of the company's board. "ReWalk provides paralyzed individuals with the ability to stand and walk, to look someone in the eye, to hug and be hugged. These are simple acts which many of our ReWalkers thought they would never be able to do again."

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ReWalk, a robotic exoskeleton that helps paraplegics walk, is the nation's first such device to be approved by the FDA.
rewalk, fda, approval, exoskeleton
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2014-50-27
Friday, 27 Jun 2014 10:50 AM
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