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SmartSurgN Visualization System Receives FDA Pre-Market Clearance

Jan 25, 2023

San Jose, CA, January 25, 2023 – SmartSurgN is pleased to announce that its Visualization System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This advanced laparoscopy camera system enhances surgical precision by facilitating Indocyanine Green (ICG) fluorescence-guided surgery.


The SmartSurgN Visualization System provides an immersive experience with fully optimized 4K resolution video, achieved through the integration of multiple imaging components. The system features the PrizMCurgNâ„¢ camera head, equipped with four CMOS sensors, including RGB and dedicated infrared sensors. These sensors process both laser (NIR) and visible light to deliver real-time fluorescence overlays on RGB video, offering unparalleled clarity and ICG-navigated precision during procedures.


Additionally, PrizMCurgN includes four illuminated buttons that streamline access to key features, enhancing operational ease that improves workflow and surgeon ergonomics.


Designed to simplify complex surgical workflows and provide enhanced information, the SmartSurgN Visualization System aims to assist surgeons in achieving improved patient outcomes.









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