BioElectronics Announces U.S. FDA Market Clearance
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Posted On: 02/03/2020 7:11:21 AM
BioElectronics Announces U.S. FDA Market Clearance for Over-The-Counter Treatment of Musculoskeletal Pain
FREDERICK, MD, Feb. 03, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the-counter marketing clearance was granted for the drug-free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.”
The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Keith Nalepka, Vice President Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain, for instance, in the back, knee, hips, wrists, elbow, and ankle.”
Kelly Whelan, President of BioElectronics, stated: “The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.”
The 510(k) application was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professors, Duke University, Ian Rawe, Ph.D., Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics.
FREDERICK, MD, Feb. 03, 2020 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE – BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com, the maker of non-invasive electroceutical devices, is pleased to announce that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new, over-the-counter marketing clearance was granted for the drug-free ActiPatch® medical device, for the indication: “adjunctive treatment of musculoskeletal pain.”
The ActiPatch was already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis (heel pain) in 2017. The latest clearance expands these indications to cover all musculoskeletal pain complaints. Keith Nalepka, Vice President Sales and Marketing, expressed confidence on exploiting the expanded market opportunity: “The expanded clearance paves the way for new products to be marketed with approved medical claims for musculoskeletal pain, for instance, in the back, knee, hips, wrists, elbow, and ankle.”
Kelly Whelan, President of BioElectronics, stated: “The Company intends to capitalize on this new clearance by offering additional products to retail channel partners, in alignment with our 2020 strategy to prioritize the OEM (Original Equipment Manufacturer) aspects of our business.” With the latest clearance, ActiPatch remains the only pulsed shortwave therapy (PSWT) device with an over-the-counter clearance for treating any form of musculoskeletal pain.”
The 510(k) application was prepared by the R&D team comprising: Kenneth McLeod, Ph.D., Director of Clinical Science and Engineering Research, State University of New York at Binghamton and Richard Staelin, Ph.D., Gregory Mario and Jeremy Mario Professors, Duke University, Ian Rawe, Ph.D., Director of Clinical Research, BioElectronics and Sree Koneru, Ph.D., VP Product Development, BioElectronics.
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