FUJIF - FDA grants 510(k) clearance for Fujifilm's new endosurgical image enhancement technology

Fujifilm Medical Systems announces that the FDA has granted 510(k) clearance for Fujifilm’s (FUJIY) new image enhancement technology - the Oxygen Saturation Endoscopic Imaging System - which was developed to improve visualization during gastrointestinal, colorectal, and advanced endoscopy and surgical procedures.This technology enables real-time visualization of hemoglobin oxygen saturation levels in tissue which helps surgeons identify potentially ischemic tissue, better positioning them to prevent tissue necrosis. This 510(k) clearance comes six months after the FDA granted Breakthrough Device Designation to Fujifilm’s new image enhancement technology and is an upgrade to ELUXEO Surgical System.

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FDA grants 510(k) clearance for Fujifilm’s new endosurgical image enhancement technology