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
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