Endo Tools Therapeutics Receives FDA Clearance for Next-Generation endomina® EZFuse System
Endo Tools Therapeutics (ETT) has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation endomina® EZFuse system.
The updated system builds on ETT’s existing suturing platform, offering a more intuitive design to enable faster suturing, improved efficiency, and enhanced usability for soft tissue approximation procedures.
Early experience with the EZFuse system shows a reduction in total procedure time of up to 50%, allowing physicians to complete procedures more efficiently without altering their established approach.
The single-movement suture mechanism removes unnecessary steps, streamlining workflow and reducing staff burden and user fatigue.
This design also helps hospitals and ambulatory surgery centres optimise resources, improve scheduling flexibility, and increase overall procedural capacity, supporting better patient care.
The company will begin commercialising the endomina® EZFuse system immediately in the U.S., with plans to expand availability in key markets worldwide.
The clearance reinforces ETT’s focus on making advanced endoscopic procedures faster, simpler, and more accessible, while enhancing operational efficiency and supporting physician adoption.
