Mauna Kea Miniprobe Receives FDA Clearance
PARIS, June 2, 2016 — Microscopy developer Mauna Kea Technologies SA has received its twelfth 510(k) clearance from the U.S. Food and Drug Administration (FDA).
The new FDA clearance covers its confocal miniprobes for use in urological and minimally invasive surgical applications with its NIR (near-infrared) Cellvizio platform. The company said its NIR imaging products are designed to provide a positive impact on procedural outcomes by adding the precision and reliability of real-time cellular characterization to fluorescence-guided procedures.
Mauna Kea is a global medical device company focused on the diagnosis and treatment of cancer through in vivo microscopic visualization.
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