Bioelectronics Corp (BIEL)

[kidnova]

But it doesn't matter what the website says..it's what's on the application that matters. If heat was not listed as the mechanism of action, then FDA was correct to identifiy it as non-thermal diathermy.

I always that the whole point of this therapy was PEMF, not heat. If heat was the mechanism of action, well, there are tons of predicate devices for that.

^This. BIEL has made a point of emphasizing in the past that their device did use or emit heat. They are doing a complete 180 here in the hopes of finding another avenue for reclassification. This is a complete hail mary IMO. They need to suck it up and start the PMA process. Actually they should have been started that 3 years ago and they may already have their products on the market by now.