Avinger Gets FDA’s 510(k) Clearance for Its Lightbox 3 for Artery Viewing

January 18, 2022

Avinger has received 510(k) clearance from the FDA for its new Lightbox 3 vascular imaging system.

The device is an intravascular, image-guided, catheter-based system for diagnosis and treatment of peripheral artery disease. It features a solid-state laser for enhanced optical coherence tomography imaging, a more powerful computing platform than previous versions, and a redesigned software system.

The new console delivers advancements in imaging, portability and capability that will support new catheter capabilities in the future, according to the Redwood City, Calif.-based company.

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