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Minnesota Medical Technologies Receives the US FDA’s 510(k) Clearance for StaySure to Manage Fecal Incontinence

Shots:

  • Minnesota Medical Technologies has reported the US FDA’s 510(k) clearance to StaySure for the management of fecal incontinence (FI)
  • A completed clinical trial demonstrated the device’s safety & efficacy, with a reduction in fecal incontinence frequency & improved QoL; full results are expected later in 2025
  • StaySure, marketed as Navina Insert in the EU, is a disposable, easy-to-use, self-inserted fecal incontinence insert made of 100% silicone with a fluid-filled design that adapts to the body for a secure & comfortable fit

Ref: PRNewswire | Image: Minnesota Medical Technologies | Press Release

Related News:- RIVANNA Receives the US FDA 510(k) Clearance for Accuro3S System and SpineNav-AI Image Processing Software

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