Newsletter
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Cellvizio News, May 2013
FDA grants Mauna Kea Technologies 510(k) clearance to market AQ-Flex™19 miniprobe for fine needle aspiration procedures Mauna Kea Technologies announced that the U.S. Food and Drug Administration (FDA) has cleared the AQ‐Flex™ 19 miniprobe to provide real‐time optical biopsies during endoscopic ultrasound‐guided fine needle aspiration (EUSFNA) procedures in the digestive tract. This represents the sixth U.S. regulatory clearance for Mauna Kea Technologies’ Cellvizio on one of its dedicated miniprobes, which already obtained the CE mark in Europe.07/05/2013
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Cellvizio News, February 2013
Cellvizio has received State Food and Drug Administration (SFDA) approval in China for gastroenterology and pulmonology We are very happy to inform you of the regulatory approval for Cellvizio in China for gastroenterology and pulmonology indications. We have entered into a strategic partnership with Fujifilm China to develop the optical biopsy market throughout China, one of the fastest-growing medical device markets in the world.15/02/2013
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Cellvizio News, October 2012
Mauna Kea Technologies makes optical biopsy available to brazilian patients. We are pleased to announce that Cellvizio imaging -- the fastest way to see cancer -- is now available to hospitals throughout Brazil, South America's largest medical device market.15/10/2012
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Cellvizio News, July 2012
The publication on Cellvizio in the Chinese Journal of Digestive Endoscopy marked an exciting first for Mauna Kea Technologies.13/07/2012
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Cellvizio News, April 2012
We are gearing up for the 4th Annual International Conference of Cellvizio Users (ICCU) being held on April 13th-15th in Rome, Italy.11/04/2012
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Cellvizio News, January 2012
Mauna Kea Technologies announces official collaborations with the American Society for Gastrointestinal Endoscopy (ASGE) and the Société Française d'Endoscopie Digestive (SFED).19/01/2012
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Cellvizio News, October 2011
It would be an understatement to say that our IPO is a major milestone in the life of our company. Its success – the largest IPO in France since early 2010 - is commensurate with the effort we have put into developing our ground-breaking technology and we are extremely happy to be in a position to take it to the next phase and to think very long term.21/10/2011
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CELLVIZIO NEWS, JULY 2011
In April we welcomed over 90 gastroenterologists and pulmonologists to the International Congress of Cellvizio Users (ICCU), where Cellvizio users met to discuss the future impact of pCLE in both disciplines as well as upcoming indications.18/07/2011
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28/01/2013
Cellvizio featured in 9news.com : World's smallest microscope finds cancer faster
St. Anthony Hospital is the first hospital in Colorado to use the new advanced-imaging technology, called Cellvizio, with at-risk patients during standard endoscopy and colonoscopy procedures as well as the pancreatic and bile duct cancer detection procedure. Cellvizio allows physicians to view internal tissues cell-by-cell to pinpoint cancerous and pre-cancerous tissue more efficiently than current procedures. Dr. Matt Reveille says the new technology helps doctors respond once they identify dangerous tissue.more
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26/11/2012
Cellvizio in the Sioux Falls Business Journal
Fantastic article by Sanford Hospital in the Sioux Falls Business Journal. "This can change the practice of medicine,” said Dr. Muslim Atiq, a gastroenterologist at Sanford. “The whole key is to find cancer before cancer occurs. To find it very early makes a big difference.”more
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29/11/2013
Endo-Update
Endo-update 2013 is a two-day interventional endoscopy update course in Augsburg, Germany, with an internationally recognized faculty highlighting the latest research, skills, and technologies with simultaneous live sessions, state-of-the-art lectures, case discussions and interactive case presentations. More details to come soon !more
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17/06/2013
CELLVIZIO DAY : TRAINING WORKSHOP AT PAOLI CALMETTES INSTITUTE - MARSEILLE, FRANCE
Acquire a basic understanding of how the Cellvizio system works, and learn how to interpret Cellvizio images of the esophagus, bile duc and colon. Live cases will be observed and the latest clinical data and case studies will be analyzed.
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13/06/2013
MAUNA KEA TECHNOLOGIES ENTERS INTO MAJOR CELLVIZIO® DISTRIBUTION AGREEMENT WITH A LEADING JAPANESE MEDICAL DEVICE COMPANY
PARIS, (June 13, 2013) – Mauna Kea Technologies (NYSE Euronext: MKEA, FR0010609263), leader in the optical biopsy market and developer of Cellvizio®, the fastest way to see cancer, reported that it has entered an exclusive distribution agreement in Japan with AMCO Inc. for a five-year period. This partnership further strengthens Mauna Kea Technologies’ ties with the Japanese market, and is a major step forward in the company’s efforts to obtain regulatory approval in the world’s second largest endoscopy device market after the US. The Japanese Ministry of Health, Labor, and Welfare (MHLW) requires foreign medical device companies to have a physical presence within the country or define a partnering distributor prior to approving a device for commercial sale.
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