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The Secret Behind FDA Approval for the ReWalk Exoskeleton

The Secret Behind FDA Approval for the ReWalk Exoskeleton

Recently I was interviewed to potentially try out the newly FDA ( Food and Drug Administration) approved ReWalk exoskeleton robot. I had seen a form online looking for persons that may be interested and I thought it was a unique opportunity so I filled out that form. The interviewer asked my location, how active I was, if I already owned a stationary stander at home and was a frequent user of it. He asked me my height, weight, and my type of disability.

About 10 minutes into the conversation the man said that I wasn't the "ideal" candidate due to the new FDA approval for the system. This was due to the fact that the FDA labels it as a mobility walking system for persons with "spinal cord injury" and by their definition, being born with a birth defect resulting in paralysis is not that.

The man told me that the system is seventy thousand dollars, but can be less expensive with a doctors recommended prescription to those whom qualify. He also told me that as of yet, my geographical location does not have a system nearby, but that there are three well known hospitals and rehabilitation facilities that are greatly interested in using the system.

The man told me that it is possible to get a recommendation from my doctor even though I am not living with a "spinal cord injury" by FDA standards. He said that due to my age, and high level of mobility and activity, that I should ask my doctors about the system and that maybe when the system arrives into my state within the year, I would be available to begin a trial run using the robotic exoskeleton.

I mentioned to the man that it was likely that my doctors would never say anything to me about the system or admit that it even exists. I said that since it is not in my state and therefore, not feasible for me to use it on a presumably regular basis, they would not say anything to me to get my hopes up.

The man agreed with me and said that he hopes once it gets set up in my state that there will be a large demand for it by patients, and that doctors will embrace it when they see it for themselves. The man and I both agreed that once people are familiar with it other than what they see from a YouTube video or read on a the internet or a brochure, that maybe things will begin to look better.

I feel as though people whom have never had a chance to use a system like this would greatly benefit more than someone whom has previously walked and will get the opportunity to try so again. I feel like this would be great for all the things the doctors tell you, such as weight bearing, range of motion, and muscle definition.

I think that the FDA should consult more with doctors and hospitals to understand and experience things for themselves to see how patients could react and benefit from a new idea or invention. Though my doctors do often refer to my lesions as "spinal injury" there is a disconnect between what I experienced from birth and what others have experienced from recreational endeavors. Medical personnel always say they want patients such as myself to have a stellar quality of life, and I feel as though this system and many others available would give that opportunity to so many.

How about a hospital bed that can be lower than a standard wheelchair?

Leave a Comment

  1. Matthew Tilford
    Matthew Tilford
    Great read. I have experienced walking in one of the few exoskeletons on the market and can say it is amazing. I hope one comes to you locally soon. Where do you live?
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