Endo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation endomina® EZFuse system

510(k) clearance enables immediate U.S. commercialization of enhanced soft tissue approximation technology in the gastrointestinal tract

“The EZFuse system clearance marks an important milestone in the continued evolution of the endomina system and introduces a number of improvements to simplify workflow and to enhance the physician experience,” said Alexandre Chau, CEO of Endo Tools Therapeutics. “We are excited that the new system is making it easier for physicians to adopt and integrate our device into their practice.”

Early procedural experience with the next generation EZFuse system demonstrates significantly faster suturing time, with a reduction of total procedure time up to 50%, enabling physicians to complete procedures more efficiently without changing their established approach

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