Bioelectronics Corp (BIEL)

[Probity]

“The 510(k) process was very messy for BIEL "way back then" but the reason for that messiness was that BIEL had trouble proving substantial equivalence to a predicate device.”

BIEL had trouble proving substantial equivalence given the predicate device? Oh, for sure!

Here’s the point you’re missing. Better to ask, why was it troublesome for the company? That “troublesome” was like BIEL living a nightmare for seemingly endless years given their predicate device was deemed to be A-ok for safety, efficacy, and for use post-blepharoplasty surgery!

Imagine that…Yes, cleared for use over the eye after eyelid surgery. Over the eye near the BRAIN. How far way is that BRAIN from the eyelid? Should have been a “slam dunk” inclusive of use for anywhere on the body.

That anticipated “slam dunk” for use with other indications given the cleared predicate device actually turned into a nightmare for BIEL…like a MOAB dropping on this small company. And now those MOAB’s keep raining down on a still small company with the crappy PPS at triple a 1-2.

Cui bono?

All imo.