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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.
This will remove the last limit on my pizza eating. I will have my own gravity field and moons. Does it come in XXXL?
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.
If I want to walk around with a glorified powered cane, why does the Food & Drug Administration need to get involved?
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.
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...
systemd is Roko's Basilisk.
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.
Here's a list https://www.accessdata.fda.gov...
Power armors when?
"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.
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.
Anons need not reply. Questions end with a question mark.
The FDA has many divisions. One, the Center for Device and Radiological Health (CDRH) classifies medical devices that aid in improving human health; this qualifies.
Also, many people do not understand the FDA's mission. The FDA is not there to validate your science. They are in fact there to validate your marketing. If you have some sort of device or potion or drug that can possibly improve human health, the FDA can stop you from marketing your device or saying it is capable of doing anything to help a person until everything you say it can do has been validated via a controlled clinical study. You also need to prove safety, efficacy, and quality control to ensure that once you make claims about what it can do it continues to do what you say it can do. But note the comment there: it's about what you claim it can do. You can't sell a product until you tell people what it's capable of, so by controlling the marketing they effectively control your business.
So yes, you can sell a device or drug without FDA approval. You simply can't tell anyone what it can do, or the FDA will shut down your business and arrest you (yes they are a badge carrying service and can arrest you). So theorhetically yes this could have been sold without approval; what the FDA approval does is they can now make claims about it improving patient lives because they've proved it can do that in a controlled study.
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, 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 devices.
As a medical device, the FDA is supposed to see how likely it is to harm you. If that device fails (batteries die, software crashes, wire shorts out...), your legs go limp and you fall. Especially in the elderly, falls can be fatal. Also in the case of a paraplegic, they want to make sure that it doesn't exceed your own range of motion and injure your legs, or pinch and draw blood (which you wouldn't feel because of the paraplegia), or who knows what else.
"FDA regulated medical device" and "available by prescription only" are not the same. Bandages are FDA regulated (they want to make sure that those things truly are sterile), and they're available at 7-eleven.
People who live in glass houses shouldn't walk and text.
Yeah, because regulating the safety of medical devices is tyrrany!
It's it funny how half of stories on slashdot about innovation always involve getting permission from some government agency? If this exoskeleton falls under the purview of the FDA, does that mean we can eat it or get high off it?
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 devices company part time while he taught. In one class he had explained how the rules from the FDA made the medical device development unprofitable. It took too long to get these devices to market so his company effectively abandoned medicine and went into veterinary devices, perhaps hoping they'd make it to human use in the future. The FDA made saving people's lives unprofitable but saving the lives of rich people's pets is where they could make money.
At some point in the past the FDA may have been beneficial to American society. That time is no more. I say fuck the FDA and let the states regulate drugs and medical devices. Theoretically states already can regulate medical devices used within their own borders but the way the federal government interprets the "interstate commerce" clause they can merely decide that something is "interstate" based on the flimsiest of evidence. That medical device may have been designed, produced, and used wholly in the state but if it is shipped from one end of the state to the other in a cardboard box made out of state then it is now "interstate commerce" and the federal government can shut them down.
I am armed because I am free. I am free because I am armed.
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 effects, both for the patient and those they interact with, must be just life sucking.
Even if this were not FDA approved I'd hope that patients, insurers, and other decision makers in this loop would realize the benefits of this technology and find a way to pay for it. Taking out a loan for this so someone can still walk to work might take ten years to pay off but that would mean someone is going to work instead of sitting at home waiting for the mail carrier to hand them a government issued check so that they can buy food for that week.
At this price range I'd think it would be worth it. I'd think that the price would come down in time with economies of scale and improvements in production. I just did a Google search for wheel chairs and a non-powered one can be had for a couple hundred dollars, a powered one can easily exceed $8000, a "cheap" one is still in the thousands. Some of the cost is offset by what one would have to pay for the alternatives. Wheelchair, ramps, perhaps an elevator, that's all a cost a person would have to bear. This tech would let them walk up steps, that alone is huge.
I am armed because I am free. I am free because I am armed.