BioElectronics Continues FDA Clearance Campaign to Bring Chronic
Pain Sufferers Safe, Effective, Inexpensive, Drug-Free Pain
Therapy
BioElectronics Continues FDA Clearance Campaign to Bring Chronic
Pain Sufferers Safe, Effective, Inexpensive, Drug-Free Pain
Therapy
PR Newswire
FREDERICK, Md., June 10, 2013
FREDERICK, Md., June 10, 2013 /PRNewswire/ -- BioElectronics
Corporation (OTC Pink: BIEL), the maker of advanced consumer
medical devices, which has sold 500,000 devices, without
prescriptions, in 57 countries reported that they have received
three letters from the Office of Science Integrity. These
letters are virtually identical in denying the firm's request for
the FDA Commissioner to review her staffs' prior decisions.
Dr. Jesse Goodman, Chief Scientist,
said, "I have determined, in my discretion, that additional Agency
consideration is not warranted" and simply suggested resubmitting
510(k) premarket notifications or "providing input into the recent
CDRH process for reclassification of non-thermal shortwave
diathermy devices."
Andrew Whelan, President of
BioElectronics said, "Despite the FDA's egregious delays associated
with applications initially filed in 2009, and our primary
international business focus, we plan to continue to pursue all
possible avenues to get OTC market clearance and bring to American
consumers the same safe and affordable pain relief enjoyed by
people around the world."
About BioElectronics Corporation
BioElectronics (www.bielcorp.com) is an award winning developer
and manufacturer of advanced medical devices. Its products are
ActiPatch® Therapy, for over-the-counter treatment of back pain and
other musculoskeletal ailments, the Allay™ Menstrual Cycle Pain
Therapy, and RecoveryRx™ for surgical procedures and wound
care.
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
SOURCE BioElectronics Corporation