Press Coverage

FDA Clearance for Cellvizio + Pafolacianine for Molecular Imaging

9 May 2022

The US FDA has granted 510(k) clearance (K220477) for the use of the Cellvizio 100 Series platform with a molecular imaging agent called Pafolacianine (Cytalux) for real-time in vivo visualization during endoscopic, laparoscopic, and needle-based procedures, according to Mauna Kea Technologies.

Latest News

Mauna Kea Technologies Reports Third Quarter 2025 Revenue Up +16% at Constant Exchange Rates 

Mauna Kea Technologies Reports Third Quarter 2025 Revenue Up +16% at Constant Exchange Rates 

Mauna Kea Technologies Announces the Terms of its Financing Under its Safeguard Plan

Mauna Kea Technologies Announces the Terms of its Financing Under its Safeguard Plan

Mauna Kea Technologies Reaches a Key Milestone in Its Financial Restructuring 

Mauna Kea Technologies Reaches a Key Milestone in Its Financial Restructuring 

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