Mauna Kea, a French firm, having recently made available its Cellvizio system in the U.S., now also won European CE Mark approval for the technology to be used during robotic-assisted surgeries. The Cellvizio Confocal Laser Endomicroscopy (CLE) System allows urologists to analyze the cellular structure of tissues as part of retroscopic and cystoscopic procedures. No samples need to be taken, as the system’s probes feature a laser scanner and a detector that give a closeup look at the tissues in vivo.
The reusable probes are introduced through an endoscope and the tip placed against the tissue to be analyzed. Real-time imaging is provided on a nearby screen, allowing physicians to assess the tissue right there and then. The tip can be repeatedly moved around to test other nearby tissues as long as necessary.
“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,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, in a statement. “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.”
Product page: Cellvizio…
Via: Mauna Kea…
Flashbacks: Mauna Kea’s Cellvizio Confocal Laser Endomicroscopy Released Through Cook Medical…; Mauna Kea AQ-Flex 19 Miniprobe for Optical GI Biopsies…; Endo-microscopy from Mauna Kea Technologies…; Mauna Kea UroFlex Optical Biopsy Probe Cleared in Europe…; Endo-microscopy Technique Shows Promise for Early Colon CA Diagnosis…; ; Cellvizio 100 Series Endomicroscopy System Obtains 510(k) Clearance from FDA…
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