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.
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?