Mauna Kea Technologies has announced that it has received FDA 510(k) clearance of the Cellvizio 100 series F400 and F800 with a Confocal Miniprobe, the CranioFlex, to be used during neurosurgical procedures. This marks the 15th U.S. FDA 510(k) clearance of Cellvizio and the first-ever FDA clearance for CLE applications in neurosurgery.
The Cellvizio 100 with the CranioFlex provides imaging of tissue internal microstructures and allows the identification of cells and vessels and their organisation within the central nervous system during cranial diagnostic and therapeutic procedures such as tumour biopsy and resection.
The Cellvizio 100 series F400 model operates at 488nm and the F800 model at 800nm, two highly relevant wavelengths commonly used during brain surgery for imaging and navigation.
“This is an important regulatory and business milestone for the Company, opening new avenues for market development and strategic partnerships,” said Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies.
“It also unlocks a new era in neurosurgery, paving the way toward more precise resection of brain and spinal tumours. Cellvizio is now the first to market endomicroscopic visualisation platform providing neurosurgeons for the first time the ability to perform real-time optical biopsies to help determine, for instance, if the tumour is completely excised".
"This clearance builds on many years of clinical development and is happening at a time when the neurosurgery community recognises the potential benefits of real-time digital visualisation of nervous system tissue microstructures.”