Bioelectronics Corp (BIEL)

[kidnova]

If you had been following the company closely you would know that BIEL has received Not Substantially Equivalent notifications from the FDA for both the Actipatch and Allay 510k filings. They are currently awaiting a response on their De Novo reclassification request. If the reclassification is approved then they will achieve category II clearance.

They expect a quicker response on the Recovery Rx 510k because it is for clearance as a class III device. It has already been approved as a class III device for a similar indication so it can use the same approved device as a predicate for the 510k application.

Perhaps you're not as up to speed on this company as you claim to be?