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FDA wants more data on Md. firm’s therapy device

BioElectronics Corp., a maker of therapy devices based in Frederick, met Oct. 3 with FDA officials to discuss the data requirements to support a musculoskeletal pain indication for their ActiPatch Musculoskeletal Pain Therapy device.

In the premarket notification for the device, BioElectronics used osteoarthritis of the knee and plantar fasciitis clinical studies, along with an explanation of the device’s mechanism of action, to support that indication. Now the FDA wants clinical data from an additional anatomical application area, according to BioElectronics, which said in a statement it would provide evidence from its UK chronic pain registry.

BioElectronics says it has data on 5,660 back pain users, supported by new data from an observational study on 117 subjects who used the therapy over a 6-month period.

 


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