{"id":3513,"date":"2026-03-17T10:00:00","date_gmt":"2026-03-17T09:00:00","guid":{"rendered":"https:\/\/www.endotools.be\/?p=3513"},"modified":"2026-03-16T10:56:08","modified_gmt":"2026-03-16T09:56:08","slug":"endo-tools-therapeutics-receives-fda-510k-clearance-for-next-generation-endomina-ezfuse-system","status":"publish","type":"post","link":"https:\/\/www.endotools.be\/us-en\/2026\/03\/17\/endo-tools-therapeutics-receives-fda-510k-clearance-for-next-generation-endomina-ezfuse-system\/","title":{"rendered":"Endo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation\u00a0Endomina\u00ae\u00a0EZFuse\u00a0system\u00a0"},"content":{"rendered":"\t\t
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Endo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation Endomina\u00ae EZFuse system <\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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  • \n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\tMarch 17, 2026\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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    \u00a0<\/p>

    510(k) clearance enables immediate U.S.\u00a0<\/span>commercialization of enhanced soft tissue approximation technology<\/span>\u00a0<\/span>in the gastrointestinal tract<\/span>\u00a0<\/span><\/span>\u00a0<\/span><\/em><\/p>

    \"\"<\/p>

    Gosselies, Belgium \u2013 March 17, 2026 \u2013<\/strong> Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its next-generation technology, the\u00a0endomina\u00ae\u00a0EZFuse\u00a0<\/span>system<\/span>. This advancement in the company\u2019s suturing platform\u00a0has been engineered with a more intuitive design\u00a0to deliver\u00a0faster suturing,\u00a0greater efficiency,\u00a0and usability for soft tissue approximation procedures.<\/span>\u00a0<\/span><\/p>

    \u201cThe\u00a0EZFuse\u00a0<\/span>s<\/span>ystem<\/span>\u00a0<\/span>clearance\u00a0marks an important milestone in the continued evolution of the\u00a0endomina\u00a0system\u00a0and introduces a number of improvements to\u00a0simplify workflow and\u00a0to\u00a0enhance\u00a0the\u00a0physician experience,\u201d said Alexandre Chau, CEO of Endo Tools Therapeutics. \u201cWe are excited that the new\u00a0system\u00a0is making it easier for physicians to adopt and integrate our device into their practice.\u201d<\/span>\u00a0<\/span><\/p>

    Early procedural experience\u00a0with the next generation\u00a0EZFuse\u00a0<\/span>system\u00a0<\/span>demonstrates\u00a0<\/span>significantly faster\u00a0<\/span>suturing time<\/span>,\u00a0<\/span>with a reduction of\u00a0<\/span>total procedure time<\/span>\u00a0<\/span>up to\u00a0<\/span>50%<\/span>, enabling physicians to complete\u00a0procedures\u00a0more efficiently without changing their established approach.\u00a0<\/span>\u00a0<\/span><\/p>

    The\u00a0<\/span>suture\u2019s\u00a0<\/span>single-movement\u00a0<\/span>mechanism eliminates unnecessary steps, creating a more streamlined workflow. The intuitive design\u00a0reduces staff and operational burden as well as minimizes user fatigue, helping clinical teams perform procedures with greater ease and predictability.\u00a0EZFuse\u00a0<\/span>suture\u00a0<\/span>reduces\u00a0complexity across the care setting,\u00a0allowing\u00a0hospitals and ambulatory surgery centers to optimize\u00a0resource utilization, improve scheduling flexibility, and expand overall procedural capacity<\/span>,\u00a0<\/span>ultim<\/span>ately lea<\/span>ding to\u00a0<\/span>improved<\/span>\u00a0patien<\/span>t care<\/span>.<\/span>\u00a0<\/span><\/p>

    Denis Gestin,\u00a0Chairman\u00a0of the Board at Endo Tools Therapeutics, added: \u201cETT has always been focused on pushing the boundaries of\u00a0what\u2019s\u00a0possible in endoscopic innovation. With the FDA clearance of\u00a0the next generation\u00a0endomina\u00ae\u00a0EZFuse\u00a0<\/span>system<\/span>, we are reinforcing our commitment\u00a0to make advanced endoscopic procedures faster, simpler, and more accessible\u00a0to\u00a0physicians while improving efficiencies for hospitals and ambulatory centers. This milestone positions the company for accelerated growth\u00a0and physician adoption\u00a0in the U.S.\u201d<\/span>\u00a0<\/span><\/p>

    The company will begin commercialization of the\u00a0endomina\u00ae\u00a0EZFuse\u00a0<\/span>system<\/span>\u00a0<\/span>immediately\u00a0in the U.S., with plans to broaden availability in key markets worldwide.<\/span>\u00a0<\/span><\/p>

    About Endo Tools Therapeutics<\/span><\/b>\u00a0<\/span><\/p>

    Located in\u00a0Gosselies, Belgium, Endo Tools Therapeutics S.A. (ETT) offers a portfolio of advanced,\u00a0incisionless\u00a0and minimally invasive endoscopic medical devices. The company\u2019s mission is to develop solutions that expand the range of gastrointestinal procedures that can be performed using standard gastroscopes. By developing minimally invasive treatment solutions, ETT aims to reduce complications and hospital length\u00a0of stay, while improving patient comfort.\u00a0In Europe and select Middle East countries, the devices are approved for endoscopic gastroplasty procedures for the treatment of obesity, with over 1,500\u00a0procedures already performed, while in the U.S. they are cleared for placement of sutures and approximation of soft tissue in the gastrointestinal tract.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

    Endo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation Endomina\u00ae EZFuse system \u00a0 510(k) clearance enables immediate U.S.\u00a0commercialization of enhanced soft tissue approximation technology\u00a0in the gastrointestinal tract\u00a0\u00a0 Gosselies, Belgium \u2013 March 17, 2026 \u2013 Endo Tools Therapeutics (ETT), developers of advanced endoscopic medical devices, today announced that the U.S. Food and Drug Administration (FDA) has […]<\/p>\n","protected":false},"author":7,"featured_media":3520,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[30],"tags":[],"class_list":["post-3513","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized-us-en"],"yoast_head":"\nEndo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation\u00a0Endomina\u00ae\u00a0EZFuse\u00a0system\u00a0 - endotools<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.endotools.be\/2026\/03\/17\/endo-tools-therapeutics-receives-fda-510k-clearance-for-next-generation-endomina-ezfuse-system\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Endo Tools Therapeutics Receives FDA 510(k) Clearance for Next-Generation\u00a0Endomina\u00ae\u00a0EZFuse\u00a0system\u00a0 - 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