BioElectronics Corp. (BIEL: OTC Pink Current) | BioElectronics and Pulsed Shortwave Therapy Make Progress

FREDERICK , Md. , May 23, 2013 /PRNewswire/— BioElectronics Corporation (OTC Pink: BIEL ), the maker of very effective, safe consumer medical devices, comments on the FDA panel meeting for non-thermal shortwave diathermy: The FDA ’s Public Advisory Panel Reclassification – Pulsed Shortwave Therapy Meeting was held on May 21, 2013 in Gaithersburg, MD , USA .  The focus of the meeting was very narrow, in that the FDA had instructed the panel to focus solely on the application of non-thermal shortwave diathermy for the treatment of postoperative pain and edema and the treatment of edema following blepharoplasty.  Industry representatives, including BioElectronics President Andy Whelan , presented a compelling case for reclassification.  The recommendation from the FDA ’s advisory panel was reclassification from Class III to Class II with special controls including a requirement for new clinical data. At this time it is not clear if the requirement for new clinical data applies to existing products.  The FDA will make a final decision on the recommendations of the panel in due course, though BioElectronics believes that the FDA will follow the panel’s recommendations.