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Medical Devices / Submissions and Approvals

FDA Clears Laser Endomicroscopy Platform

Dec. 26, 2017

Mauna Kea received 510(k) clearance from the FDA for its Cellvizio multidisciplinary confocal laser endomicroscopy platform.

The agency based the clearance on data from peer-reviewed medical journals that validated the device’s capacity to image tissue microstructures.

Clearing this hurdle will allow the company to shift its focus from imaging to identification, according to the firm’s founder and CEO Sacha Loiseau.

The College of American Pathologists reported high potential value for in vivo microscopy technology, saying it reduced sampling errors and costs.

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