“We are confident that the FDA will view the new data favorably and help us get to the finish line of getting clearance for general musculoskeletal pain. The Company will submit the new 510(k) application within the next few weeks. Due to heightened efficiency and new review guidelines at the FDA, the turnaround time on the 510(k) will be relatively short,” said Dr. Sree Koneru, Ph.D., VP of Product Development for BioElectronics.