Mauna Kea Technologies Receives FDA 510(k) Clearance of Cellvizio® with a Fluorescent Dye, Fluorescein, as Drug Device Combination
The Cellvizio® 100 series system with all its different Confocal Miniprobes™ is now cleared for use with the fluorescein dye to image blood flow in the microvasculature and capillaries.
Cellvizio Needle-Based AQ-Flex™ 19 Confocal Miniprobe™ Enabling Peripheral Lung Nodule Targeting and Imaging Receives 510(k) Clearance
This marks the 16th U.S. FDA 510(k) clearance of the Cellvizio® p/nCLE platform.
First Published Report of Live “Tele-Cellvizio®” Utilization In Vivo between Surgeons and Remote Pathologists
This scientific publication, entitled "Intraoperative confocal laser endomicroscopy for real-time in vivo tissue characterization during surgical procedures", reports on outcomes of 21 consecutive patients that underwent laparoscopic surgery at the Institut Mutualiste Montsouris (IMM) in Paris, France, between 2014 and 2015.
Positive Results from Mayo Clinic Sponsored Prospective Multi-center Trial in Lung Transplant Patients
“The lung has the highest rate of acute rejection of any transplanted organ,” said Cesar Keller, M.D., Lung Transplant Program, Mayo Clinic, Jacksonville, Florida and first author of the study. “However, the current standard of care, transbronchial biopsy, requires multiple samples to be obtained per biopsy and carries a high risk of serious adverse events including pneumothorax and/or pulmonary bleeding. Considering the relatively frequent need to monitor these patients for acute rejection, better and less invasive methods to assess acute rejection would significantly improve patient care and outcomes.”
Cellvizio® Demonstrates Superior Identification of Patients at Risk for Esophageal Cancer Compared to Current Diagnostic Standard
Results from new clinical study that enrolled 172 patients at 8 non-academic centers in the United-States was presented at 2018 World Congress of Endoscopic Surgery hosted by SAGES and CAGS.
Mauna Kea Technologies: Largest Cellvizio Study To Date Demonstrates Near Perfect Correlation with Histology in Key GI Procedures
April 3, 2017 Mauna Kea Technologies inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy platform, today announced the presentation of data from the National French Registry on Cellvizio® procedures confirming the strong performance of confocal laser endomicroscopy (CLE)...