Breaking Update
CE Mark Approval Clears Path for Israeli EndoZip Obesity Treatment in Europe
CE Mark approval paves way for Israeli EndoZip obesity treatment in Europe. Nitinotes introduces automated suturing system for endoscopic sleeve gastroplasty,
Jerusalem, 6 November, 2025 (TPS-IL) — Israeli medical device company Nitinotes Ltd. has received CE Mark approval for EndoZip, the first fully automated suturing system for endoscopic sleeve gastroplasty (ESG). The certification allows Nitinotes to market the device across the European Union and other CE Mark-accepting countries.
EndoZip automates the ESG procedure, enabling single-physician operation, shorter treatment times, and broader patient access. It offers a minimally invasive alternative for adults with obesity who have not succeeded with diet, exercise, or medication. Nitinotes plans to launch the system in select European centers while preparing for a pivotal U.S. trial to support future FDA approval.
