FDA Clears Mauna Kea’s Endomicroscopy Platform for Use with Fluorescent Dye

Mauna Kea has received 510(k) clearance for its Cellvizio 100 endomicroscopy platform and associated microprobes for visualizing blood flow using a fluorescent dye (fluorescein) as a drug-device combination.

The Cellvizio system images the internal microstructure of tissues, identifying cells and vessels and their architecture.

The newly cleared indication allows the platform to be used “with highly specific molecular imaging markers,” according to the company’s CEO Robert Gershon.