At present, BioElectronics’ products’ FDA approval is limited to the treatment of edema following blepharoplasty (eye surgery).
Kristen Jeffery, brand manager of RecoveryRx, said: “This additional clearance will allow BioElectronics to market to all surgical specialties for providing pain relief for post-surgical wounds. Our products have sold very well internationally for C-Sections, Hernias, and other surgeries and we expect this further clearance to significantly increase US sales.”
BioElectronics received a not substantially equivalent (NSE) letter from the FDA in response to 510(K) application for ActiPatch to be sold over-the-counter for the treatment of musculoskeletal pain.
The FDA’s decision is predicated on their assertion that the pulsed electromagnetic device category is restricted to treatment of postoperative pain and edema, not musculoskeletal conditions. As a result, BioElectronics has formally requested that the ActiPatch 510(k) product application be changed to Section 513(f)(2) De Novo Classification.
The De Novo process is a request to create a new product category. BioElectronics continues to provide the FDA with additional research and clinical evidence to support this premarketing clearance.
BioElectronics has developed a new prescription device for the treatment of chronic pain that will be eligible for reimbursement by Medicare, Medicaid and private insurers.
Andrew Whelan, CEO, said: “We were not fully satisfied with the initial version and we have built an enhanced model. We expect to complete the testing and file the 510(k) application within the next few weeks.”
