FDA Gives Nod to Mauna Kea Miniprobes
Mauna Kea announced the FDA granted 510(k) clearance to its CelioFlex confocal miniprobes, designed for use with its Cellvizio device.
The probes provide visualization during laparascopic, endoscopic and robotic-assisted procedures. The approval will enhance providers’ ability to generate imaging for robotic-assisted procedures, according to company founder and CEO Sacha Loiseau.
Cellvizio applications have received clearance in more than 40 countries, including the U.S., Europe, Japan, China, Canada, Brazil and Mexico. Last month, the company released trial data supporting the use of the device in diagnosing pancreatic cysts.