US EditionOlympus Secures FDA Clearance for Most Advanced Imaging Endoscopes
- On May 27, 2025, Olympus disclosed that the FDA had granted regulatory clearance for its EZ1500 line of endoscopes at its Center Valley, Pennsylvania location.
- This clearance comes after Olympus introduced advanced imaging capabilities in its EZ1500 series endoscopes designed to maintain a sharp focus across varying depths, enhancing visualization during gastrointestinal examinations.
- The EZ1500 series includes the GIF-EZ1500 gastroscope and CF-EZ1500DL/I colonoscope, both using EDOF to deliver continuously sharp images with minimal focal adjustment.
- EDOF technology splits light into near- and far-focused beams that combine into a wide depth of field image, allowing a 3mm normal mode distance and improved visibility over prior scopes.
- Olympus states that this approval supports its goal to elevate endoscopy standards and help physicians achieve better clinical outcomes in gastrointestinal procedures.
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Olympus receives FDA clearance for new endoscopes
Center Valley-based Olympus said it has received FDA 510(k) clearance for a new endoscope technology it has developed — the EZ1500 series endoscopes featuring Extended Depth of Field. The endoscopes, which include the GIF-EZ1500 gastroscope and the CF-EZ1500DL/I colonoscope, represent Olympus’ most advanced imaging and latest innovation as part of its EVIS X1 endoscopy system, the company said. By allowing physicians to obtain sharp images, ED…
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