FDA Clears Endomina EZFuse System for GI Suturing

Endo Tools Therapeutics said the device is designed to make internal GI suturing faster and easier during endoscopic procedures.

The FDA has granted 510(k) clearance to Endo Tools Therapeutics’ endomina EZFuse system, a device used in endoscopic procedures to bring tissue together inside the gastrointestinal, or GI, tract. It helps physicians place internal stitches during less invasive procedures performed through the digestive tract, avoiding the need for open surgery.

The Belgium-based company stated that the cleared device is its next-gen suturing platform. It is intended for what is known as soft tissue approximation in the GI tract. This term refers to bringing tissue together during a procedure, often to support closure or repair inside the digestive system.

According to Endo Tools Therapeutics, the EZFuse system was designed with a more intuitive design to support faster suturing, greater efficiency and improved usability. The company noted that early procedural experience with the next-generation system showed significantly faster suturing times, with total procedure time reduced by up to 50% while allowing physicians to maintain their established procedural approach.

Endo Tools Therapeutics also mentioned that the device uses a single-movement suturing mechanism that removes unnecessary steps and creates a more streamlined workflow. For hospitals and care teams, this could mean less staff and operational burden, reduced user fatigue and more predictable procedures. 

The company added that the system may help hospitals and outpatient surgery centers improve scheduling flexibility, better utilize resources and expand procedural capacity. Outpatient surgery centers are facilities where patients can undergo same-day procedures without staying overnight in a hospital.

Endo Tools Therapeutics announced it will begin commercializing the EZFuse system immediately in the US, with plans to expand availability in key markets worldwide.

What Is Driving Innovation in GI Surgery and Suturing Technologies?

More companies are working to make complex GI procedures easier to perform. 

In September 2025, EndoQuest Robotics announced that a gastroenterologist completed the first fully robotic endoscopic submucosal dissection, or ESD, in its PARADIGM trial. This is an FDA Investigational Device Exemption (IDE) pivotal study evaluating the company’s endoluminal surgical system for lower GI tract procedures. ESD is a minimally invasive technique used to remove certain early lesions in the GI tract. However, it is known to be technically challenging and has a steep learning curve.

Overall, the suturing market is being driven by demand for minimally invasive procedures, which a recent market report says account for nearly 45% of total procedures. This shift also reflects the rise of robotic-assisted surgery and interest in more precise suturing tools. The report also highlights the growing use of antimicrobial, biodegradable and barbed sutures.

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