Mauna Kea wins expanded FDA 510(k) for Cellvizio

Mauna Kea (ENT:MKEA) said today it won expanded FDA 510(k) clearance for its Cellvizio confocal laser endomicroscopy platform and its Confocal Miniprobe devices.

The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level. The system allows the operating physician to visualize the internal microstructure of tissue in real time during ureteroscopic and cytoscopic procedures, Mauna Kea said.

With the expanded clearance, the device is now indicated for identification of cells and vessels and their organizations and architecture, the Paris-based company said. The clearance was based on data from peer-reviewed medical journals which Mauna Kea said validated the platform’s ability to image internal microstructures of tissues.

Mauna Kea said that the new clearance was a pivotal milestone for the platform and the company.

“With this new clearance, Cellvizio is affirmed as the only platform for imaging and identification at the cellular and micro-vascular level during a wide variety of procedures in endoscopy and surgery This milestone enables us to formally shift from imaging to identification, providing us with strong leverage to broaden adoption by healthcare providers and payers,” CEO Sacha Loiseau said in a press release.

In October, Mauna Kea released data from a Cellvizio study exploring the use of the system to diagnose pancreatic cysts, touting improved diagnoses and patient management.

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