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www.fdanews.com/articles/204147-mauna-kea-technologies-gets-510k-clearance-for-blood-flow-imaging-product
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Mauna Kea Technologies Gets 510(k) Clearance for Blood Flow Imaging Product

August 27, 2021

Mauna Kea Technologies’ Cellvizio laser endomicroscopy platform has received 510(k) clearance for the FDA for use with fluorescein dye to image blood flow in the microvasculature and capillaries.

The imaging platform is used in gastroenterology, pulmonology and urology during endoscopic procedures, as well as laparoscopic and robot-assisted surgeries.

The latest version of the platform includes several new features, including the use of artificial intelligence (AI) for pattern recognition.

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