4 News & Press Releases found
Mauna Kea Technologies News
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Mauna Kea Technologies Receives FDA Clearance and CE Marking For Its Next-Generation Cellvizio® Platform
The new Cellvizio®platform includes significant improvements and will enable major innovations Mauna Kea Technologies announced today that it has obtained 510(k) clearance (K193416) from the U.S. Food and Drug Administration (FDA) ...
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Mauna Kea Technologies Receives FDA 510(k) Clearance of Cellvizio® with a Fluorescent Dye, Fluorescein, as Drug Device Combination
The Cellvizio®100 series system with all its different Confocal Miniprobes™ is now cleared for use with the fluorescein dye to image blood flow in the microvasculature and capillaries Mauna Kea Technologies today announced that ...
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Positive Results on Needle-Based Endomicroscopy for the Clinical Management of Pancreatic Cystic Lesions
Clinical trial published in peer-reviewed journal demonstrates diagnostic yield from Cellvizio®significantly exceeds standard of care (84.1% vs 34.1%); use of Cellvizio drives overall change in clinical management - including need for continued ...
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Mauna Kea Technologies Participates in Dutch Molecular Imaging Consortium that was Awarded €5.4 Million
MEDPHOT consortium aims to develop light-based molecular imaging solution for pulmonary diseases Mauna Kea Technologies today announced it is part of a molecular imaging consortium that was awarded €5.4 million by the Perspective ...