FREDERICK, Md., Feb. 27, 2014 /PRNewswire/ -- Medical device
researchers and clinicians are optimistically supportive of the
Food and Drug Administration's decision last week to reclassify and
rename electronic shortwave diathermy for many other uses, a
decision that may improve access to safe, clinically tested medical
devices that serve as alternatives to risky pain medications.
Officials with Frederick,
MD-based BioElectronics Corp. (OTC Pink: BIEL), makers of
inexpensive, disposable medication-free anti-inflammatory medical
devices, said its extensive clinical and laboratory data underscore
the FDA's new direction regarding shortwave medical devices.
"We are enthusiastic about the FDA's new decision as it
galvanizes the international medical community's scientific view of
these safe and effective medical devices," said Lawrence L. Michaelis MD, Emeritus Professor of
Surgery, Feinberg School of Medicine of
Northwestern University and Head of the Medical Advisory
Board of BioElectronics Corp. "These effective, low-cost products
are available over-the-counter all over the rest of the
world. Clinical data from many studies have proven the
efficacy of these alternative therapies and hundreds of thousands
of patients outside of the U.S. have benefitted from them - without
any known adverse side effects."
Dr. Michaelis said the company will be submitting data from a
number of clinical and laboratory studies to the FDA as the company
seeks new 510K applications for reclassified and renamed medical
devices. "Patients who suffer from chronic or acute musculoskeletal
pain deserve access to more than just high risk pain medications,"
he said. "We are very pleased with the FDA's new approach to these
devices."
About BioElectronics Corporation
BioElectronics
Corporation is a leader in biophysics and the maker of an industry
leading family of disposable, drug-free, pain treatment devices:
ActiPatch® Therapy, over-the-counter treatment for
back pain and other musculoskeletal complaints;
RecoveryRx® Devices for chronic and post-operative
wound care; HealFast®Therapy (www.healfasttherapy.com)
and the Allay® Menstrual Pain Therapy. More info:
http://www.bielcorp.com.
Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
SOURCE BioElectronics Corporation