FDA approves Mauna Kea tool for use with its confocal laser endomicroscopy system

Aug. 21, 2017

The intended use is to provide visualization of body cavities, organs, and canals during robotic-assisted procedures.

Mauna Kea Technologies (Paris, France) has received U.S. FDA clearance for its CelioFlex UHD Confocal Miniprobes for use with its Cellvizio confocal laser endomicroscopy platform in robotic-assisted surgery procedures. The intended use of CelioFlex UHD Confocal Miniprobes is to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robotic-assisted procedures.

The new FDA clearance for the company helps to meet its Cellvizio product roadmap and market expansion strategy, says Sacha Loiseau, Ph.D., founder and CEO of Mauna Kea Technologies. The ability to instantaneously visualize and characterize tissue at the cellular level as a natural extension to robotic-assisted procedures to enable data-driven surgery will in part rely on advanced imaging and machine learning algorithms to provide reliable, real-time tissue information to surgeons, Loiseau adds.

This is the 13th FDA clearance covering the Cellvizio system.

For more information, please visit www.maunakeatech.com.