I vividly recall much reading and discussions with the former CEO and many others on the innocent error by BIEL that FDA staff actually uncovered.
That, in fact, BIEL had erroneously claimed in its sincere understanding and belief, for years, that the efficacy of BIEL devices was heat related.
FDA scientists had discovered, after scientific testing and assessment, and advised BIEL they determined it was not. Former management fought the FDA claim tooth and nail for months, until the FDA scientists showed scientific proof it was not.
Only then did BIEL back down from its stance of empty defiance and follow the mature recommendation of FDA that BIEL simply re-file without the heat component, which is exactly what happened and thus the birth on non-thermal Short Wave Therapy, an FDA re-naming of the former PEMF. FDA staff believed there was a stigma attached to PEMF, which there was and felt BIEL really had something great, so it was renamed in a new category.
That is what transpired and no amount of protestation or obfuscation is going to change what I see in writing and what has been posted here many times over the years. My involvement in the board discussion began with post 29398, April 3, 2013. It was a revelation by the FDA, a sharp learning curve by all and I know I made 123 subsequent references to heat thereafter, including today. There were hundreds of others by interesting people here.
FDA made no error, FDA discovered an unwitting error and worked together patiently with BIEL to help resolve the previous misunderstanding and assumptions of the science! I also vividly recall stating to the former CEO, "Why are you arguing with the FDA, what is wrong with you? Say thank you and get on with getting to market and making money!" That was not the preference. . . . it was very strange . . . .
