Replies to post #157353 on Bioelectronics Corp (BIEL)

[pinhigh]

Any product that is accepted into the Challenge is a winner of sorts. It's the FDA's way of saying to CompanyXYZ that they see some merit in the product as presented. Few will be declared outright winners, but it will still be a feather in the caps of those that make the field. Go Biel$$$

[Chyna9]

It's only for devices, I don't think there are categories.

RecoveryRx is what was entered.

IMO it doesn't match up well with the criteria given (see link).

https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm


RR is a post-surgical device. I just don't think it's what they are looking for in the challenge. Seems much more about end-user devices/products, and nothing at all related to post-op. I'll happily be wrong if it does get accepted. I will put the odds at 15% right now.

The company had said they were working on and going to submit a 510k on rr, and then did a bait and switch (IMO) and entered the challenge instead. If it's not accepted, who knows if they will end up doing one or not. They obviously should, and shoulda coulda woulda been done years ago at this point.

They should be notified by end of the month on if they got accepted or not, and give an update regardless. JMHO but they aren't known to be the best communicators. gl