Mauna Kea (ENT:MKEA) said today it won FDA 510(k) clearance for its CelioFlex UHD confocal miniprobes designed for use with its Cellvizio device in robotic-assisted surgery.
The CelioFlex UHD probes are designed to provide visualization of body cavities, organs and canals during endoscopic, laparoscopic and robotic-assisted procedures, the Paris-based company said.
“This new FDA clearance is an important milestone for the company on its Cellvizio product roadmap and market expansion strategy. We see the ability to instantaneously visualize and characterize tissue at the cellular level as a natural extension to robotic-assisted procedures and enabling data-driven surgery, which will in-part rely on advanced imaging and machine learning algorithms to provide reliable, real-time tissue information to surgeons,” founder & CEO Sacha Loiseau said in a press release.
Last month, Mauna Kea touted the results from a recently published study of its Cellvizio system which supported the use of the device in diagnosing pancreatic cysts.