Additional Clearance Awarded to Cook Medical Endomicroscopy System

March 21, 2018

The FDA granted further 510(k) clearance to Cook Medical’s Cellvizio confocal laser endomicroscopy (CLE) system after data from multiple peer-reviewed journals supported a new indication for the system.

The probe-based CLE system uses laser scanning technology to create real-time images of internal tissue microstructure.

The new indication allows the product to be used for in vivo imaging of the internal microstructure of tissues, helping urologists identify cells, vessels and their architectures during endoscopic procedures.

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