Replies to post #54249 on Bioelectronics Corp (BIEL)

[User_347763]

What I see is conflict of interest and hypocrisy as far as the FDA is concerned.
That is how I perceive it. What is going on inside the FDA I do not know (corruption, blackmail, incompetence,arrogance,...?) and frankly I do not give a damn.
They could have reclassified in 2014 ... not sure it will happen this year.
But I am convinced BIEL will succeed (in the USA) in 2016 no matter what...
We do not hear much about B.Braun...but that will change in the coming months

[ddls]

A 73 MicroWatt "paradigm shift"? No! Not This!

to deal with the plethora of emerging medical devices

And more than half of them FDA-NSE snake oil gizmos, including this one.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm292029.htm

Most manufacturers do not want to be FDA approved. You read that correctly; they are not seeking FDA approval. There are many reasons for this, including the high price tag associated with seeking FDA approval. FDA approval also comes with the stipulation that the product be condition-specific. Because PEMF devices treat us at such a basic, cellular level, choosing only one health condition would be a disservice to both the brand and the consumer. Additionally, PEMF systems are, first and foremost, wellness devices. It is not medication – a magnetic field does not have to be processed by the body like medications do. A magnetic field acts on the most basic of biological functions – the cellular level. It’s more physics than medicine.

Why a small company like BioElectronics is pursuing FDA still is laughable.