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FDA Approves Indego Exoskeleton For Clinical And Personal Use (vanderbilt.edu)
Science_afficionado writes to note that the FDA "has approved a powered lower-limb exoskeleton created by a team of Vanderbilt engineers and commercialized by the Parker Hannifin Corporation for both clinical and personal use in the United States." Indego, which allows people paralyzed below the waist to stand up and walk, is the result of an intensive, 10-year effort. The initial development was funded by a grant from the National Institute of Child Health and Human Development. The device acts like an external skeleton as it straps in tightly around the torso. Rigid supports are strapped to the legs and extend from the hip to the knee and from the knee to the foot. The hip and knee joints are driven by computer-controlled electric motors powered by advanced batteries. The device operates a lot like a Segway with legs and the minimalist design allows users to take it on and off while sitting in a wheelchair. Indego's clearance came after completion of the largest exoskeleton clinical trial conducted in the United States. It has been available in Europe since November, when it received the CE Mark, the European Union's equivalent of FDA approval. The initial price is $80,000.
Or you know, they are no longer functionally disabled and can find a wider range of employment. In the long run, they are less of a fiscal burden. Call it investing in your citizens.
It costs 80 grand for a week of certain cancer medicines. Take it easy, bucko. You haven't made enough money to pay taxes since you got your associate's degree in Computer Technology.
You are welcome on my lawn.
FDA => Food and Drug Administration. Is this something to be eaten? No, it's a mechanical device. No doubt it's use has benefits for people with a variety of medical conditions but I fail to see why this needs FDA approval to get on the market. Even in the article they equate much of it's capability to that of a Segway, did the Segway need FDA approval before it could come on the market?
Perhaps I'm reading more into this than I should. Was this marketable before, without the FDA approving it? I'm trying to think of how they'd define this as a medical device, requiring some sort of medical approval for use, when there are all kinds of mechanical devices that can improve mobility and strength for the disabled and able bodied alike.
Speaking of which, imagine how an able bodied person might take advantage of this technology. This technology might make a person able to carry 70 pounds for a mile and turn that person that can carry 200 pounds for two miles. Think of the search and rescue applications. Cranes and trucks can do a lot of things but if you have the mobility of a person with the lifting capacity of a small forklift then you've got something amazing.
I am armed because I am free. I am free because I am armed.
They could build and market it for general use and not require any approval whatsoever. FDA approval as a 'medical device' means that it is eligible for government subsidies and opens the door for private insurers also. Even wheelchairs have to be FDA approved.