This is FANTASTIC news! The fact that the meeting garnered the time and attention of senior management from the FDA's Neurology and Physical Medicine group is a solid indication that they not only are taking this seriously, but this so very close now to receiving clearance.
And the work BIEL has done in the UK is now paying off---big time. Those UK registry studies on back pain are solid---solid enough to convince the UK and will be vital in meeting the FDA's request for that third study.
Great, great news. Almost there Longs!
Pending U.S. FDA Market Clearance for Over-the-Counter Sales
We had a second status meeting with the FDA on Wednesday, July 20, 2016. Senior Management from the Neurology and Physical Medicine Group, 4 examiners, the Head of the Physical Medicine, and the project statistician were present. The meeting went well and the tenor was very good.