Bioelectronics Corp (BIEL)

[kidnova]

I have in no way read all of the recent studies regarding PEMF, but as far as I can tell BIEL is the only one arguing for heat as the mechanism of action. Read the comments submitted by the other PEMF companies posted on Regulations.gov, for example.

Ivivi:

Ivivi Health Sciences has dedicated considerable resources to elucidate the mechanism of action
of its signals. Studies have been carried out at the molecular, cellular, animal and human levels which
have led to the understanding that Ivivi devices act, not via heat, but in a signaling capacity which can
modulate the biological response to physical and chemical insult. As will unfold below, these studies
have significantly advanced knowledge in this area and will help FDA address safety and effectiveness
concerns.

Regenesis, who goes to great lengths to explain the difference between IMJ and ILX.
http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0378-0017

Anyways, there are obviously two different topics being discussed:

1) Is BIEL's product incorrectly classified, which is being addressed in their specific petitions to their 510K rejections. Personally I don't think this is a valid argument, but I'm no scientist.

2) Should ALL diathermy "non-thermal" devices be classified as Class III requiring a PMA (the FDAs proposal), reclassified as Class II devices requiring special controls (which the manufacturers obviously want), or left as they are. This is the topic that was supposed to be addressed at the FDA meeting. Who knows when they'll get back around to it now?

Good discussion today guys, I enjoyed it.