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.
Braun Medical Includes BioElectronics ActiPatch Medical Device in Its Same Day Knee and Hip Surgical Program
FREDERICK, MD., May 31, 2018 (GLOBE NEWSWIRE) — BioElectronics Corporation (OTC PINK: BIEL), maker of advanced medical devices announces that B. Braun Ltd, of Sheffield, UK has recently completed development of its same day surgical TOTAL Pathway program for joint replacements which includes BioElectronics medical devices. The program is being launched by B. Braun’s UK Group to improve care and reduce the UK healthcare cost of its 160,000 annual hip and knee replacement procedures.