FDA Clears Cook Medical Laser Endomicroscopy

FDA has cleared a Cook Medical 510(k) for the Cellvizio Confocal Laser Endomicroscopy System and the Confocal Miniprobes. “Additional data provided in multiple peer-reviewed medical journals paved the way for this new clearance and indication for the Cellvizio system,” the company says. With the clearance, the device can be used for in vivo imaging of the internal microstructure of tissues, including the identification of cells and vessels and their organization or architecture during endoscopic procedures. The probe-based device is a visualization platform that incorporates laser scanning technology to generate images of the internal microstructure of tissues, the company says. It is made up of optical fiber bundles and other optical elements, which transmit laser light to the tissue site and detect the fluorescence signal that is emitted back into real-time images.