This is the text of a press release by Mauna Kea on the FDA approval of their product in May:
"Paris and Boston, May 24, 2018 – 5.45 PM CEST – Mauna Kea Technologies(Euronext: MKEA, OTCQX: MKEAY)inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announcedthat it has received U.S. Food and Drug Administration (FDA) 510(k) clearance of the Cellvizio® 100 series F400and F800 with a new Confocal Miniprobe™, the CranioFlex™, to be used during neurosurgical procedures. Thismarks the 15th U.S. FDA 510(k) clearance of Cellvizio® and the first-ever FDA clearance for CLE applications inneurosurgery.The Cellvizio® 100 with the CranioFlex™ provides imaging of tissue internal microstructures and allows theidentification of cells and vessels and their organization within the central nervous system during cranialdiagnostic and therapeutic procedures such as tumor biopsy and resection. The Cellvizio 100 series F400 modeloperates at 488 nm and the F800 model at 800 nm, two highly relevant wavelengths commonly used duringbrain surgery for imaging and navigation.“This is an important regulatory and business milestone for the Company, opening new avenues for marketdevelopment and strategic partnerships,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer ofMauna Kea Technologies. “It also unlocks a new era in neurosurgery, paving the way toward more preciseresection of brain and spinal tumors. Cellvizio® is now the first to market endomicroscopic visualizationplatform providing neurosurgeons for the first time the ability to perform real-time optical biopsies to helpdetermine, for instance, if the tumor is completely excised. This clearance builds on many years of clinicaldevelopment and is happening at a time when the neurosurgery community recognizes the potential benefitsof real-time digital visualization of nervous system tissue microstructures.”
Perhaps we will hear something from OIL soon.
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This is the text of a press release by Mauna Kea on the FDA...
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