An Israeli designed device, the ReWalk, that allows paraplegics to walk was granted FDA approval Friday for home use in the United States.
The new FDA approval means ReWalk’s maker, Argo Medical Technologies, or Argo, can now market its products in the U.S. Over the past few years, Argo and other companies that make similar products have tested their exoskeletons on people. Argo has previously sold ReWalk devices to rehabilitation centers in the U.S. but the FDA approval marks the start of sales of ReWalk devices to Americans for private use. Each device will likely cost $65,000 to $68,000, the Telegram reported in March.
The FDA’s announcement about ReWalk details what it is-and isn’t-cleared for. It’s approved for specific spinal cord injuries, but it’s not recommended for people with other severe neurological injuries. The FDA also says users should undergo training before strapping the ReWalk on, and so should a helper for the user-maybe a spouse or a home health aide. Interestingly, the announcement also says the device isn’t for climbing stairs. This is a departure from some earlier news reports about the ReWalk, which showed users going up stairs in the exoskeleton.
The technology website, Cnet, described the device:
ReWalk exoskeletons work by attaching a wearable motorized brace to users, which they can control with a computer and motion sensors. This system lets paraplegics independently stand upright, turn, and walk, while also using crutches. Such movement gives people with spinal cord injuries added health benefits such as cardiovascular improvements, loss of fat tissue, and muscle gain.
CBS profiled an American man who participated in the clinical trials.
“I’m just so excited; I wish I had it on. I could just jump up and down,” Robert Woo told CBS News today. “It’s a great leap forward for a lot of us who are confined to wheelchairs.”…
Though Woo only had the opportunity to use the device for a few short months, he said the ReWalk vastly improved his quality of life and allowed him to be less sedentary, a problem people with paralysis face.
When ReWalk was first introduced in 2008 Israel21c profiled its inventor, Amit Goffer.
After an accident left Israeli entrepreneur Amit Goffer as a quadriplegic, he decided to develop a system that allows wheelchair users to walk, climb stairs and meet the world eye-to-eye. …
“What we want to do is have the person wake up in the morning, put on clothes, put on the ReWalk, go to work and go throughout the day, wearing it,” Dr. Amit Goffer PhD, founder and director of Argo, and ReWalk’s developer, tells ISRAEL21c.
Last year when President Barack Obama was in Israel, Prime Minister Benjamin showed him the Rewalk. SEE HERE.
At the Innovation Showcase at the 2013 AIPAC Policy Conference, an American Rewalk user, Daniel Webb, met its inventor, Amit Goffer. SEE HERE.