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Largest Pharmacists Association in US Runs ActiPatch/FDA Story

FDA expands clearance for OTC pain device

FDA has granted a new marketing clearance for an OTC electromagnetic neuromodulation device for treating pain (ActiPatch—BioElectronics Corp). The device, which was previously cleared to treat knee osteoarthritis and plantar fasciitis in 2017, is now cleared for adjunctive treatment of any musculoskeletal pain.

FDA has granted a new marketing clearance for an OTC electromagnetic neuromodulation device for treating pain (ActiPatch—BioElectronics Corp). The device, which was previously cleared to treat knee osteoarthritis and plantar fasciitis in 2017, is now cleared for adjunctive treatment of any musculoskeletal pain. BioElectronics plans to capitalize on the new 510(k) clearance by offering additional products to retail channel partners, noting that its device is the only pulsed shortwave therapy with this type of clearance and indication. Results from a long-term prospective study of the device were published last year in Pain Research and Management. The study included 240 participants with chronic pain and found that 97% of the patients sustained a 60% reduction in pain at 6 months. One pain management specialist noted at the time that although there appeared to possibly be some clinically significant effects, more research should be conducted.

https://www.pharmacist.com/article/fda-expands-clearance-otc-pain-device

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