Bioelectronics Corp (BIEL)

[colorofmoney]

It means they can go to market just a different process based on the class of product..It is a huge win....

All manufacturers who seek to market medical devices in the United States must first pass a very thorough process with the FDA through one of two pathways—the section 510(k) process, where a device is “cleared” for distribution, or the Premarket Approval (PMA) process, where a device is “approved” by the FDA.