FDA Approves Indego Exoskeleton For Clinical And Personal Use (vanderbilt.edu) 20
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.
Re:80 freaking grand? (Score:4, Insightful)
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.
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Let's see, $80k is perhaps what a typical experienced engineer, executive, or other white collar worker would make in a year. Even a someone with a blue collar job or someone starting out in IT might make that in two years. A person without technology like this might end up in a wheelchair and end up stuck at a job with much lower pay, like answering phones, end up without a job on disability, or suffer complications and get further injury because they could not move around. Just the psychological effect
Re:80 freaking grand? (Score:5, Interesting)
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.
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"It better not be my tax or insurance dollars that pay for these damn things."
$80K is the early-adopter price, which like the early-adopter price of anything else, will come down rapidly as manufacturers jump into the market. But whoops, it touches the human body, so as with hearing aids the FDA has jurisdiction over it. The price will stay ridiculous for generations to come.
FDA approval? Why? (Score:4, Interesting)
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.
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Such were my thoughts as well.
...has approved a powered lower-limb exoskeleton [...] for both clinical and personal use in the United States.
Would they be poking their oar in if it was marketed simply as a toy for the lazy, like a segway or a "hoverboard"?
Here I am, using my leg muscles like a chump...
Re:FDA approval? Why? (Score:4, Informative)
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I fail to see why this needs FDA approval to get on the market
it doesn't. however, it does need FDA approval for it to be considered a medical device that could be covered by medical insurance. the same thing is true of wheelchairs.
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This comes under FDA jurisdiction because it is a medical device: something to help disabled people with their disability. Segways aren't medical devices, they're transports for able-bodied people. The precursor to the Segway is the iBot [wikipedia.org], a wheelchair which can balance on two wheels, climb stairs, and raise its occupant to standing height. That used to be an FDA Class III medical device, recently reclassified as an FDA Class II medical device. For that matter, all wheelchairs are FDA regulated medical d
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Yeah, because regulating the safety of medical devices is tyrrany!
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If you are not outraged then you aren't paying attention.
There are numerous stories of the FDA holding up testing and treatment out of this desire for safety. I don't know how many but numerous drugs for potentially fatal diseases have been held up because the FDA thinks the drugs are not safe. The patients are desperate, they've given their informed consent, but the FDA will not allow the tests to proceed out of desire to keep the patients safe.
I had a professor in college that worked for a medical devic