BioElectronics files FDA 510(k) application for expanded clearance for ActiPatch.
BioElectronics Corporation announced that it has filed a 510(k), Premarket Notification application with the U.S. Food and Drug Administration. The application is to seek expanded market clearance for the drug free, over-the-counter ActiPatch Musculoskeletal Pain Therapy medical device for the indication: "adjunctive treatment of musculoskeletal complaints pain." The cervical osteoarthritis study submitted directly compares the effectiveness of ActiPatch treatment to that of a standard of care treatment: prescription NSAID therapy, Etoricoxib 60mg. Subjects were randomly assigned either to receive the Etoricoxib therapy or ActiPatch. Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID treatment.
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|Date:||Aug 20, 2019|
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