Bioelectronics Corp (BIEL)

[markjohn62]

Timing for the Recovery Rx 510k. I wanted to find out whether they were going to submit a 510k before, during or after the FDA challenge. It turns out they are working with the FDA to find the best path.


From Sree Koneru

Thank you for your e-mail. We are in the process of seeking guidance from the FDA on the appropriate time to submit the RecoveryRx 510(k), with respect to the Innovation Challenge. The Allay study is going strong and we expect a timely completion this year, however we do not have additional information on when the 510(k) will be filed. Any updates that we have regarding these two matters will be made publicly available via a press release.