Minnesota Medical Technologies secures FDA 510(k) clearance for fecal incontinence device 

Minnesota Medical Technologies (MMT), a medical device company based in Stewartville, Minnesota, has received FDA 510(k) clearance for StaySure™, a self-inserted device designed to help manage fecal incontinence (FI) and accidental bowel leakage (ABL). 

StaySure™ is made of soft, medical-grade silicone and filled with an encased fluid that allows it to flex and move with the body. The device sits comfortably in the rectum and is designed to prevent leakage — offering an alternative to traditional absorbent or external products. 

A Shift toward prevention 

Unlike most solutions on the market that absorb or contain leakage after it happens, StaySure™ is meant to prevent leakage entirely. 

“While most incontinence products attempt to contain or absorb leakage, StaySure™ is designed to prevent ABL altogether,” said Anthony J. Conway, Chairman and Founder of the company. “That makes StaySure™ not only an elegant solution but also the most innovative approach to managing FI symptoms on the market today.” 

Also read: EU must act on health security: MEP Adam Jarubas speaks with MedTech World

StaySure™ has already been in use in parts of Europe since 2021 under the name Navina Insert, distributed through a partnership with Wellspect Healthcare. Clinical evaluations in Europe, and more recently at the Mayo Clinic in the U.S., have shown that the device can reduce episodes of leakage and improve overall quality of life. Full results from the Mayo trial are expected later this year. 

Market launch and next steps 

With U.S. regulatory clearance now secured, the company is preparing to bring the device to market stateside. MMT has been quietly building its production capabilities in recent years in anticipation of this milestone. 

“We are thrilled to have received U.S. regulatory clearance for StaySure™, and I want to congratulate our product development and regulatory teams for their excellent work in achieving this important milestone for the company,” said David A. Jonas, CEO of Minnesota Medical Technologies. 

StaySure™ is intended for individuals living with chronic fecal incontinence — a condition often underdiagnosed and stigmatized, despite affecting millions of people in the U.S. alone. With this clearance, MMT now enters a relatively underserved space with a device that prioritizes comfort, discretion, and autonomy. 

Also read: Cybersecurity is patient safety: Blue Goat Cyber’s mission to secure medtech

Meet the innovators at MedTech Malta 2025 

Be part of the global medtech conversation this 12-14 November 2025 in Valletta, Malta, at MedTech Malta — the flagship event for founders, regulators, clinicians, and investors advancing healthcare innovation. 

Whether you’re looking to: 

• Pitch your startup in front of top-tier investors, 
• Speak on stage alongside industry leaders, 
• Or network with 2,000+ attendees,

MedTech Malta 2025 offers unmatched access to the people and ideas driving progress in medical technology. 

Secure your pass now!

To get involved, reach out to us at [email protected] 

From emerging technologies to regulatory insights, and everything in between, there’s a place for every voice in the MedTech conversation.