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 Largest Annual Pancreatic Cyst Consortium at Digestive Disease Week® 2025 

Mauna Kea Technologies Announces Largest Annual Pancreatic Cyst Consortium at Digestive Disease Week® 2025 

Publication of the 2024 Annual Financial Report 

Publication of the 2024 Annual Financial Report 

Mauna Kea Technologies Announces Another Milestone Year at Digestive Disease Week® 2025 with 8 Presentations Demonstrating the Clinical Value of Cellvizio® in Key Indications 

Mauna Kea Technologies Announces Another Milestone Year at Digestive Disease Week® 2025 with 8 Presentations Demonstrating the Clinical Value of Cellvizio® in Key Indications 

No results found.