Mauna Kea Technologies received FDA 510(k) clearance for the Cellvizio 100 series F400 and F800 with a new Confocal Miniprobe, the CranioFlex, for use in neurosurgical procedures.
Here are four things to know:
1. This is the 15th FDA approval for Cellvizio and the first FDA clearance for confocal laser endomicroscopy in neurosurgery.
2. The Cellvizio 100 with the CranioFlex provides imaging of tissue internal microstructures, enabling providers to identify cells and vessels and their organization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.
3. The series is intended to provide more precise resection of brain and spinal tumors.
4. The Cellvizio 100 series F400 model operates at 488 nm and the F800 model at 800 nm, two wavelengths commonly used during brain surgery for imaging and navigation purposes.
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