Mauna Kea lands 510(k), CE Mark for next-gen Cellvizio platform

Mauna Kea (ENT:MKEA) this week said it won FDA clearance and CE Mark approval for its next-generation Cellvizio endomicroscopy platform.
The Cellvizio uses modular design solutions to better integrate endomicroscopy in procedure suites and third-party platforms. The new platform was designed to facilitate future developments that include deep learning capabilities for assisted image interpretation. It’s also ergonomic and has a reduced footprint that can be easily integrated into laparoscopic, advanced navigation and robotic systems, according to Mauna Kea.
“We are proud to announce the FDA clearance and CE marking of our next generation Cellvizio in the U.S. and Europe,” CEO Robert Gershon said in a news release. “The next generation Cellvizio platform will be launched commercially in the coming months and, with its modular and flexible designs as well as being AI and molecular imaging ready, will host our future innovations, indications and support partnership developments.”
Cellvizio has a completely redesigned user interface with a new touchscreen and single-handed probe connection for easier setup and use. It is designed to being more precise imaging to patients with nine dedicated Confocal Miniprobes.
Original Article: (https://www.massdevice.com/mauna-kea-lands-510k-ce-mark-for-next-gen-cellvizio-platform/)