I have been hinting at this exact conspiracy construct for months now. Thus, consider, the FDA has already cleared two of BIEL's products. The technology upon which BIEL's devices are based are well known. Hence, there are no surprises for anybody who is involved in this situation, in regards to the FDA approval process.
Furthermore, isn't it kinda curious that an FDA "Additional Information Request" notice is received by BIEL within a window of a week or two before the clearance decision is expected to be announced? If I'm not mistaken, this scenario took place during the last two BIEL 510(k) submissions. Hmm! Yeah, almost as if these ignominious debacles were rehearsed. Or, maybe with a wink /nod, have the end results play out as expected. Something stinks here folks! Of course, this is all reasonable conjecture on my part, y'all. All MO!!
GLTA!!!
P.S. IMO, BIEL has solid grounds for court action against the FDA from the standpoint of violation of public trust, for starters, if the FDA is indeed unduly rejecting their 510(k). But, if there is some skullduggery going on from related angles here, then...?
News 
Market Data 
Discover 
