FDAnews
www.fdanews.com/articles/196119-mauna-kea-technologies-endomicroscopy-platform-gains-clearance

Mauna Kea Technologies’ Endomicroscopy Platform Gains Clearance

March 4, 2020

Mauna Kea Technologies has received CE Mark certification and the FDA’s 510(k) clearance for the next generation version of its Cellvizio endomicroscopy system.

The platform’s hardware and software were designed to allow for future developments, including AI capabilities for image interpretation, the company said.

Cellvizio integrates with laparoscopic, advanced navigation, and robotic systems, and can use other endomicroscopy devices for fluorescence-guided surgery and molecular imaging.

View today's stories