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Comment by otoburb | Hacker News Reader

What would it actually take to get this type of device approved for human use in terms of regulatory approval? The article doesn't go into details. I have a heuristic that projects at least 10 years into the future for drugs/devices at this early stage of development assuming funding is secured, but not sure if this still holds.

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The wired version of this device was in human trials ~10 years ago through cyberkinetics, a startup spun out of brown to commercialize the technology. See NYT article from 2004 talking about the start of their clinical trials: http://www.nytimes.com/2004/04/13/health/13BRAI.html

It's usually pretty quick/easy to get stuff approved for in-lab, early human trials. But yeah, much longer until it's available to the public.

>>It's usually pretty quick/easy to get stuff approved for in-lab, early human trials.

I'm surprised -- I thought that even if you had an eager group of volunteers for in-lab, early human trials you still needed to jump through understandably onerous red tape and provide reams of documentation and evidence that the device was safe.

Or does signing a (supposedly ironclad) waiver absolve your right as an early human trial participant to sue in the event of failure or adverse side effects?

shortcut is a humanitarian device exemption (HDE) if you have some good preliminary data, not sure what the exact rules are.

there is deep brain stimulation - has been around for 2 decades, although innovation was stagnant because of the patent on its use (basically a rejiggered cardiac pacemaker design). patent now expired, 2 competitor companies readying devices on the market...all sorts of exciting new stuff on the horizon (well FDA timescale which 5 years or so)...

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