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Re: Three years for development and 10 years to prove it?
_hm   6/22/2014 6:28:56 AM
@Ron: My worry is major nerve system which resides in very close proximity. And they also work on similar signals and may not like this pulses.


Ron Neale
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Re: Three years for development and 10 years to prove it?
Ron Neale   6/22/2014 4:55:07 AM
_hm:- I understand the regulations in the USA and UK, Europe are different and will certainly have some impact on the timing once the procedure is fully developed and proven. To make any judgement of our own we need to know a few quantitative details with respect to: the voltage, the current, the pulse width, shape and repitition rate. How is the contact made to the active material solvent or electrolyte and how long the process takes. At some point we assume the pulses are carried by a metal to a hard or soft electrode (cloth soaked in electrolyte)either carrying the electrolyte or in contact with it and in contact with the tooth. What is the electrolyte?

At least there will some serious work for designers in the electronics industry to make an electric pulse generator and prove that it is safe and reliable enough to put into the patients mouth. That proof will be a serious part of the qualification step for whatever the country the device is used. I will attempt to find some answers to some of the questions in the next few days. I understand a formal work will be published in the near future.

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Three years for development and 10 years to prove it?
_hm   6/21/2014 8:01:51 PM
It is good that will be available in 3 years. Will it need 10 more years to prove that it is safe and no other detrimental effects?

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