BioElectronics researchers and clinicians support US FDA’s position to reclassify shortwave medical devices to Class II
Maryland
Saturday, March 01, 2014, 13:00 Hrs [IST]
Medical device researchers and clinicians at BioElectronics Corp. are optimistically supportive of the US Food and Drug Administration (FDA)’s decision last week to reclassify and rename electronic shortwave diathermy for many other uses, a decision that may improve access to safe, clinically tested medical devices that serve as alternatives to risky pain medications.
Officials with Frederick, Maryland-based BioElectronics Corp., makers of inexpensive, disposable medication-free anti-inflammatory medical devices, said its extensive clinical and laboratory data underscore the FDA’s new direction regarding shortwave medical devices.
“We are enthusiastic about the FDA’s new decision as it galvanizes the international medical community’s scientific view of these safe and effective medical devices,” said Lawrence L Michaelis MD, emeritus professor of Surgery, Feinberg School of Medicine of Northwestern University and head of the Medical Advisory Board of BioElectronics Corp. “These effective, low-cost products are available over-the-counter all over the rest of the world. Clinical data from many studies have proven the efficacy of these alternative therapies and hundreds of thousands of patients outside of the US have benefitted from them – without any known adverse side effects.”
Dr Michaelis said the company will be submitting data from a number of clinical and laboratory studies to the FDA as the company seeks new 510K applications for reclassified and renamed medical devices. “Patients who suffer from chronic or acute musculoskeletal pain deserve access to more than just high risk pain medications,” he said. “We are very pleased with the FDA’s new approach to these devices.”
BioElectronics Corporation is a leader in biophysics and the maker of an industry leading family of disposable, drug-free, pain treatment devices: ActiPatch Therapy, over-the-counter treatment for back pain and other musculoskeletal complaints; RecoveryRx Devices for chronic and post-operative wound care; HealFast Therapy and the Allay Menstrual Pain Therapy.
