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 Receives NMPA Regulatory Approval in China for its Next-Generation Cellvizio® Platform 

Mauna Kea Technologies Receives NMPA Regulatory Approval in China for its Next-Generation Cellvizio® Platform 

Mauna Kea Technologies Announces the Successful Completion of Its Financial Restructuring and €6M Capital Raise 

Mauna Kea Technologies Announces the Successful Completion of Its Financial Restructuring and €6M Capital Raise 

Mauna Kea Technologies Exits Safeguard Proceedings Following Court Approval of its Plan and Initiates Minimum €5M Capital Raise 

Mauna Kea Technologies Exits Safeguard Proceedings Following Court Approval of its Plan and Initiates Minimum €5M Capital Raise 

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