Bioelectronics Corp (BIEL)

[DDGUY]

Just looking into the 06/08/2016 FDA Update:

The meeting ended upon the FDA’s management committing to review the information and slides presented during the meeting, and to address the two regulatory issues: (1) the regulatory pathway (510(k) premarket notification or de novo submission) and, (2) the applicable timeframe.
On June 8, an FDA representative notified company counsel that the agency believes that the 510(k) pathway may be available for the ActiPatch device, the agency staff is reviewing the company’s data, and the agency would be back to the company shortly with its pathway determination and advice regarding whether additional information is necessary.
http://www.bielcorp.com/bioelectronics-company-update-june-8-2016/

Now on FDA website (shows products without prescription that are substantially equivalent
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?ID=4720&min_report_year=2007&manufacturer=MRT%2C%20INC%2E&pmndecision=SUBSTANTIALLY%20EQUIVALENT#MRT, INC.

with that said it could still be months away from approval..