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 Expanded Clinical Evidence for Cellvizio® To Be Presented at Digestive Disease Week® 2026 

Mauna Kea Technologies Announces Expanded Clinical Evidence for Cellvizio® To Be Presented at Digestive Disease Week® 2026 

Mauna Kea Technologies Reports FY 2025 Financial Results: Comprehensive Debt Restructuring and Reaccelerating Organic Growth Mark a Transformative 2025 

Mauna Kea Technologies Reports FY 2025 Financial Results: Comprehensive Debt Restructuring and Reaccelerating Organic Growth Mark a Transformative 2025 

Mauna Kea Technologies Reports Strong Q1 2026 Core Sales Growth 

Mauna Kea Technologies Reports Strong Q1 2026 Core Sales Growth 

No results found.