On August 21, 2026, the FDA granted De Novo authorization to Brixton Biosciences’ ReneuRx (Neural Ice), establishing a Class II category for injectable devices that treat musculoskeletal pain through thermal energy exchange.
Putting Pain on Ice: FDA Opens a New Chapter in Injectable Nerve Treatment
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De Novo classificationinjectable cryoneurolysisknee osteoarthritis pain21 CFR 888.3048
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