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Mauna Kea endomicroscopy system wins FDA nod

Mauna Kea Technologies has received the US Food and Drug Administration (FDA) approval for its next-generation endomicroscopy system - Cellvizio 100 Series to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts.

Cellvizio, a probe-based Confocal Laser Endomicroscopy (pCLE) system, is used in gastroenterology applications to aid physicians with real-time microscopic images of tissue inside the body.

The Cellvizio 100 Series integrates enhanced image quality and a ‘Cine Review’ feature that aids physicians to focus on a single frame of clinical evidence for as long as necessary.

The images facilitate the diagnosis and surveillance of patients, improving the detection of pre-cancerous lesions and helps physicians to make immediate treatment decisions for their patients.

Other features include an improved user interface, faster start up and shut down times, and data exchange allowing images to be exported to patient’s medical files with ease, claims Mauna Kea.