Mauna Kea Technologies passes another key regulatory milestone on its ambitious product roadmap, positioning Cellvizio as a key technology to enhance surgical robotics
Mauna Kea Technologies today announced that it has received CE Mark for its CelioFlex™ UHD Confocal Miniprobes™ for use with Cellvizio in robotic-assisted surgery procedures. The Company announced in August 2017 that it received United States Food and Drug Administration (FDA) 510(k) clearance for the same indication.
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.
Robotic-assisted surgery allows doctors to perform many types of complex procedures with greater precision, flexibility and control than is possible with conventional techniques. There are more than 700 Da Vinci robotic surgical systems installed in Europe, with more than 100,000 robotic-assisted procedures performed on these systems in 20161.
Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “This new CE Mark is a key regulatory and product milestone for the company, building on years of development and efforts to adapt its unique endomicroscopy platform to a wide variety of clinical settings. This includes surgical robotics, which is the fastest growing segment in surgery. This demonstrates our ability to strengthening Cellvizio’s value proposition and to expanding its addressable market opportunity, such as with our worldwide commercial partner in urology, Cook Medical. Following the recent FDA clearance for the same robotic-assisted procedure indication in the U.S, we have received positive feedback from and we look forward to advancing Cellvizio in this application in Europe.”
