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FDA Approves Neuspera Device for Urinary Incontinence – Medwire

FDA Approves Neuspera Device for Urinary Incontinence

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The FDA has approved Neuspera Medical’s integrated sacral neuromodulation (iSNM) system for treating urinary urge incontinence (UUI).

The smart, miniaturized implant is paired with an external wearable disc, enabling daily therapy without implanted batteries. Worn for about two hours a day, the disc charges wirelessly and activates neuromodulation therapy discreetly.

In a 128-patient study, 84% saw a 50%+ reduction in UUI symptoms, matching traditional SNM outcomes.

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