BioElectronics Receives FDA Pre-Submission Approva
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Posted On: 05/29/2018 1:15:50 PM
BioElectronics Receives FDA Pre-Submission Approval for its Post-Operation Pain Market Clearance Application
FREDERICK, MD, May 29, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com reports that it has cancelled today’s scheduled US Food and Drug Administration meeting. “The FDA’s response to our questions, suggestions, and instructions are more than adequate for us to proceed with filing of the formal 510(k) Market Clearance Application," stated Ian Rawe, Ph.D. BioElectronics’ Director of Research. The FDA’s Pre-Submission Program is designed to provide guidance and feedback on clinical data and the correct regulatory pathway to expedite market clearance.
While RecoveryRx is already US FDA cleared and available for treatment following eyelid surgery, the expanded market clearance would allow use by millions of Americans annually, who undergo a surgical procedure including hip and knee joint replacements and general surgery. RecoveryRx provides an adjunctive or alternative treatment to analgesics for postoperative pain and can reduce the need for opiate analgesics during postoperative recovery. Upon its review of the submitted information the FDA has provided written feedback and guidance for a 510(k) application to obtain expanded market clearance for treatment of postoperative pain.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.bielcorp.com
Contact:
Paul Knopick
FREDERICK, MD, May 29, 2018 (GLOBE NEWSWIRE) -- BioElectronics Corporation (OTC PINK: BIEL), www.bielcorp.com reports that it has cancelled today’s scheduled US Food and Drug Administration meeting. “The FDA’s response to our questions, suggestions, and instructions are more than adequate for us to proceed with filing of the formal 510(k) Market Clearance Application," stated Ian Rawe, Ph.D. BioElectronics’ Director of Research. The FDA’s Pre-Submission Program is designed to provide guidance and feedback on clinical data and the correct regulatory pathway to expedite market clearance.
While RecoveryRx is already US FDA cleared and available for treatment following eyelid surgery, the expanded market clearance would allow use by millions of Americans annually, who undergo a surgical procedure including hip and knee joint replacements and general surgery. RecoveryRx provides an adjunctive or alternative treatment to analgesics for postoperative pain and can reduce the need for opiate analgesics during postoperative recovery. Upon its review of the submitted information the FDA has provided written feedback and guidance for a 510(k) application to obtain expanded market clearance for treatment of postoperative pain.
About BioElectronics Corporation
BioElectronics Corporation is a leader in non-invasive electroceuticals and the maker of an industry leading family of disposable, drug-free, pain therapy devices: ActiPatch® Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx® Devices for chronic and post-operative wound care; Allay® Menstrual Pain Therapy. For more information, please visit www.bielcorp.com
Contact:
Paul Knopick
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