- The FDA grants 510(k) clearance for Mauna Kea Technologies' (OTCQX:MKEAY) CranioFlex, its new Confocal Miniprobe used with laser endomicroscope Cellvizio 100 series F400 and F800, for use in neurosurgical procedures.
- CEO Sacha Loiseau, Ph.D., says, “This is an important regulatory and business milestone for the Company, opening new avenues for market development and strategic partnerships. 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.”
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