FREDERICK, Md., Feb. 21, 2014 /PRNewswire/ -- BioElectronics
Corporation (OTC Pink: BIEL), the maker of disposable drug-free
healing pain therapy devices welcomed the FDA recommendations
announced today in their Docket No. FDA-2012-N-0378, "Physical
Medicine Devices; Reclassification and Renaming of Shortwave
Diathermy for All Other Uses."
"We are pleased that the FDA is reclassifying this technology to
reflect its safety and efficacy," said Andrew J. Whelan, President,
BioElectronics. The FDA's recommendation makes scientific
evidence the determinant for additional market clearances."
Whelan reported, we will be responding to the call for new 510K
applications with our extensive published clinical data and with
new clinical trial data generated from, randomized, placebo
controlled studies conducted at some of the world's leading medical
institutions. We are confident that our scientific and
clinical data will enable us to obtain equivalent U.S. market
clearances to those we have earned in Canada, the European Common Market and much of
the rest of the world.
"We are grateful to our customers and shareholders for their
input to the FDA in the process that lead to today's
recommendation. U.S. consumers need ready access to this
safe, drug-free and cost-effective technology that offers superior
pain relief and accelerates healing," Whelan said.
About BioElectronics Corporation
BioElectronics is
the leader in consumer medical devices that reduce pain,
inflammation and accelerate healing. Its products are
ActiPatch® Musculoskeletal Pain Therapy for back, knee, and other
musculoskeletal complaints; RecoveryRx® for chronic and
post-operative wound care; HealFast® Veterinary Therapy, Allay®
Menstrual Pain Therapy and Smart Insole™ Heel Pain Therapy.
Visit www.bielcorp.com for more information.
BioElectronics Contact:
Paul Knopick
940.262.3584
pknopick@eandecommunications.com
SOURCE BioElectronics Corporation