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Medical Devices / Submissions and Approvals

Mauna Kea Receives New 510(k) Clearance for Cellvizio

Feb. 27, 2019
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The FDA granted Mauna Kea Technologies 510(k) clearance for an additional feature of its Cellvizio laser endomicroscopy platform, the Cellvizio AQ-Flex 19 Confocal Miniprobe.

The miniprobe can be used through the working channel of existing endoscopy products to provide direct “through the needle” visualization inside peripheral lesions in the lungs. The needle-based Confocal Laser Endomicroscopy enables more precise guidance for sampling.

Mauna Kea CEO Robert L. Gershon called the FDA clearance “an important regulatory milestone” for the company and said the miniprobe “unlocks a new era in interventional pulmonology.”

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