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 Accelerates International Expansion with New Regulatory Clearances in Switzerland and the United Kingdom 

Mauna Kea Technologies Accelerates International Expansion with New Regulatory Clearances in Switzerland and the United Kingdom 

Mauna Kea Technologies Announces CE MDR Certification For Cellvizio® and Its Associated Probes

Mauna Kea Technologies Announces CE MDR Certification For Cellvizio® and Its Associated Probes

Mauna Kea Technologies Announces New Commercial Organization to Accelerate Growth Outside the United States

Mauna Kea Technologies Announces New Commercial Organization to Accelerate Growth Outside the United States

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