Mauna Kea‘s (Paris, France) Cellvizio 100 series F400 and F800, with a new Confocal Miniprobe called CranioFle, has been granted FDA clearance to be used in neurological procedures targeting brain and spinal tumors.
The confocal laser endomicroscopy system allows clinicians to analyze the cellular structure and characteristics of tissues right in the operating room.
The system relies on a variety of reusable probes that integrate a scanning laser and a detector that images the tissue. The probes can be delivered through an endoscope, the tip of which is placed against the tissue of interest. Images are immediately displayed in real-time on the system’s screen and the probe can be moved against the tissue to analyze different areas in a single procedure.
“This is an important regulatory and business milestone for the Company, opening new avenues for market development and strategic partnerships,” in a statement said Sacha Loiseau, Ph.D., Founder and CEO of Mauna Kea Technologies. “It also unlocks a new era in neurosurgery, paving the way toward more precise resection of brain and spinal tumors. Cellvizio®is now the first to market endomicroscopic visualization platform providing neurosurgeons for the first time the ability to perform real-time optical biopsies to help determine, for instance, if the tumor is completely excised. This clearance builds on many years of clinical development and is happening at a time when the neurosurgery community recognizes the potential benefits of real-time digital visualization of nervous system tissue microstructures.”
Flashbacks: Mauna Kea’s Cellvizio Confocal Laser Endomicroscopy Released Through Cook Medical…; Endo-microscopy from Mauna Kea Technologies…; 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…
Product page: Cellvizio…
Via: Mauna Kea…
