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 Announces 2026 Half-Year Results 

Mauna Kea Technologies Announces 2026 Half-Year Results 

Mauna Kea Technologies Announces Publication of a Landmark Systematic Review and Meta-Analysis Reinforcing the Diagnostic Accuracy and Clinical Impact of Cellvizio in Upper Gastrointestinal Cancer 

Mauna Kea Technologies Announces Publication of a Landmark Systematic Review and Meta-Analysis Reinforcing the Diagnostic Accuracy and Clinical Impact of Cellvizio in Upper Gastrointestinal Cancer 

Mauna Kea Technologies Announces Two New Peer-Reviewed Clinical Studies Confirming the Clinical Value of Cellvizio® and Its Combination with AI for the Diagnosis of Pancreatic Cysts 

Mauna Kea Technologies Announces Two New Peer-Reviewed Clinical Studies Confirming the Clinical Value of Cellvizio® and Its Combination with AI for the Diagnosis of Pancreatic Cysts 

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