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 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 

Mauna Kea Technologies Reports Strong H1 2026 Core Sales Growth 

Mauna Kea Technologies Reports Strong H1 2026 Core Sales Growth 

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