MAUNA KEA TECHNOLOGIES obtains the CE label for its Cellvizio-GI
Released on = January 25, 2006, 3:40 am
Press Release Author = Milestones
Industry = Healthcare
Press Release Summary = MAUNA KEA TECHNOLOGIES, leader in the field of high resolution molecular imaging for biomedical research, announces today that it received the CE label (European Conformity) in compliance with the European directives for medical devices, for its systems of fibered confocal fluorescence microscopy technology in human Gastro-Intestinal applications (Cellvizio®-GI).
Press Release Body = Paris (France), January 13th 2006 - MAUNA KEA TECHNOLOGIES, leader in the field of high resolution molecular imaging for biomedical research, announces today that it received the CE label (European Conformity) in compliance with the European directives for medical devices, for its systems of fibered confocal fluorescence microscopy technology in human Gastro-Intestinal applications (Cellvizio®-GI).
This European validation takes place only three months after obtaining the 510 (k) from the US Food and Drug Administration (FDA), confirming that the Cellvizio®-GI system meets all requirements for safety and performance demanded by the legal authorities.
Displaying the CE logo on the Cellvizio®-GI system certifies that the product complies with all European legal requirements for safety and performance requested by medical appliances and allows, as of today, the sale and the use of the system within the entire European Union.
"Obtaining the CE label for the Cellvizio®-GI at the beginning of 2006, as planned, is a significant milestone for MAUNA KEA TECHNOLOGIES", declares Sacha Loiseau, President of MAUNA KEA TECHNOLOGIES, \"It proves that our microscopic imaging solutions meet the quality and safety criteria imposed by the legal authorities on both sides of the Atlantic. Mauna Kea Technologies is now ready to launch on the market the Cellvizio®-GI, a system that enables real time microscopic visualization in the gastro-intestinal tract, in conjunction with any conventional endoscope."
At the same time, MAUNA KEA TECHNOLOGIES has obtained the ISO 13485 certification, which defines the quality standard for design, development and production of cellular imaging systems. This certification was achieved thanks to the strong professional commitment of all MAUNA KEA TECHNOLOGIES' teams.
Already known as a leader in the field of small animal cellular and molecular imaging, MAUNA KEA TECHNOLOGIES demonstrates, thanks to its recent developments, the strong versatility of its fibered confocal microscopy technology. The Cellvizio®-GI system enables the gastroenterologists to observe in vivo and in situ the digestive tract at the cellular level, an innovative, flexible and micro invasive solution that perfectly fits into their usual practice. MAUNA KEA TECHNOLOGIES will eventually develop a range of tools dedicated to other areas of medical specializations, the objective being to identify serious pathologies at an early stage.
About MAUNA KEA TECHNOLOGIES
Founded in 2000 and run by Sacha Loiseau and Benjamin Abrat, MAUNA KEA TECHNOLOGIES is already known as a international leader in the field of in vivo high resolution molecular and cellular imaging for biomedical applications. MAUNEA KEA TECHNOLOGIES has developed the world's smallest microscope that enables observations either on living animals for research applications or on patients for medical applications, notably in digestive endoscopy. Developed at the crossroads of optics, biology, medicine and image processing, MAUNA KEA TECHNOLOGIES offers unique solutions based on a strong proprietary core technology focused on "Fibered Confocal Fluorescence Microscopy". Based in Paris, the company has currently over 40 employees.
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