Bioelectronics Corp (BIEL)

[kidnova]

Well, I knew that as well, but thought that BIEL might at least file something relevant to the topic to try and support the ILX devices being reclassed to class II in case their other petitions were denied. I was wrong.

Did you read the section where they describe the current scientific studies available to support effectiveness? They were very critical. It does look like the FDA thinks that the category should be moved to class II, but it looks like there will be quite a bit of additional data required to prove effectiveness, particularly for edema which is what BIEL is currently approved for.