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 and TaeWoong Medical USA Announce Exclusive Partnership to Accelerate Commercial Expansion in the U.S. in Pancreatic Cyst Management 

Mauna Kea Technologies and TaeWoong Medical USA Announce Exclusive Partnership to Accelerate Commercial Expansion in the U.S. in Pancreatic Cyst Management 

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 

No results found.