Key Developments: Mauna Kea Technologies SA (MKEA.PA)

MKEA.PA on Paris Stock Exchange

17 Apr 2014
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Latest Key Developments (Source: Significant Developments)

Mauna Kea Technologies installs first three Cellvizio systems and obtains key regulatory clearances in Brazil
Monday, 31 Mar 2014 12:00pm EDT 

Mauna Kea Technologies SA:Says its Cellvizio system is or will soon be available at three hospitals in Brazil: ICESP (Cancer Institute of the Sao Paulo University), INCA (National Cancer Institute in Rio de Janeiro), and FUGAST (Gastroenterology Institute of Rio Grande do Sul).Says ANVISA, National Health Surveillance Agency in Brazil, has cleared the company to sell its miniprobe for direct pancreatic cyst imaging, the AQ-Flex 19, as well as its first miniprobe for urology, UroFlex and its Optical Biopsy software platform, EVA, Endomicroscopy Virtual Assistant.  Full Article

Mauna Kea Technologies equips three new clinics with Cellvizio
Tuesday, 18 Mar 2014 01:25pm EDT 

Mauna Kea Technologies SA:Says three French private clinics have been equipped with Cellvizio and provide patients in their region with clinical and therapeutic solutions offered by optical biopsy in multiple indications, including gastroenterology, pulmonology and urology.20 Cellvizio systems dedicated to clinical use already installed in France, including 11 in public hospitals and 9 in private healthcare institutions, as well as 25 in preclinical research centers.Systems installed in northern Aquitaine, Champagne and Cote d'Azur regions.  Full Article

Mauna Kea Technologies obtains FDA clearance for Cellvizio in urology
Wednesday, 5 Mar 2014 12:26pm EST 

Mauna Kea Technologies SA:Obtains 510(k) regulatory clearance from the U.S. Food & Drug Administration (FDA) for Cellvizio in the field of urology.Clearance covers the use of Cellvizio's Uroflex B and CystoFlex F Confocal Miniprobes within anatomical tracts including but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.  Full Article

Mauna Kea Technologies installs first Cellvizio System in India
Wednesday, 19 Feb 2014 12:16pm EST 

Mauna Kea Technologies SA:Says to have installed its Cellvizio system at the Apollo Gleneagles Hospital in Kolkata, a gastroenterology center in India, part of the Apollo Hospitals Group.Says this is the first medical site in India to provide such healthcare services.  Full Article

Mauna Kea Technologies SA partners with Imperial College of London on research into optical biopsy with Cellvizio
Thursday, 12 Dec 2013 12:28pm EST 

Mauna Kea Technologies SA:Says it has entered into a research collaboration agreement with the Imperial College London to develop next generation computer vision features for the use of optical biopsy based on the Cellvizio technology platform.The initiative aims to develop new imaging capabilities to improve the optical biopsy procedure and make it completely intuitive to clinicians of all specialties.  Full Article

Mauna Kea Technologies SA Receives CE Mark for Its Range of Probes for Endourological Applications
Thursday, 21 Nov 2013 11:45am EST 

Mauna Kea Technologies SA announced the granting of the CE Mark and the pre-launch of a comprehensive range of probes aimed at endourological applications. This range of probes will provide access to the flexible cystoscopy, rigid cystoscopy and ureteroscopy (CystoFlex, CystoFlex UHD and UroFlex probes respectively) procedures market.  Full Article

Mauna Kea Technologies SA Launches Optical Biopsy Operating System
Thursday, 14 Nov 2013 12:14pm EST 

Mauna Kea Technologies SA announced the launch of EVA, the Endomicroscopy Virtual Assistant, designed to be used with Cellvizio at all stages from image acquisition to review and documentation in the patient's health record. EVA is powered by the new Cellvizio software, available for sale in Europe and in the USA for digestive, pulmonary and urological applications. EVA's SmartReview highlights the stable segments within Cellvizio videos for an Optical Biopsy procedure review. Moreover, with FastExtract, EVA permits an immediate selection of the video clips identified by SmartReview. Finally, EVA's Atlas provides reference videos for each organ and pathology, directly available on the Cellvizio system. EVA's DICOM connectivity facilitates integration of Cellvizio into the hospital information system for digital archiving and transmission of Optical Biopsy data all over the hospital. With QuickReport, through a template, EVA generates print-ready reports for the patient’s electronic health record. Through a redesigned user interface, EVA allows physicians to make annotations on images, and provides a remote service solution for better assistance.  Full Article

Mauna Kea Technologies SA Announces First Use of Optical Biopsy with Cellvizio in Robotic Assisted Prostatectomy
Tuesday, 5 Nov 2013 11:45am EST 

Mauna Kea Technologies SA announced that Joseph C. Liao MD, associate professor of urology, Stanford University, has successfully used endomicroscopy with Cellvizio for the first time in eight patients treated with robotic assisted radical prostatectomy (RARP) procedures. Results were presented in a poster presentation at the 2013 World Congress of Endourology Meeting in New Orleans. In the feasibility study the use of endomicroscopy with Cellvizio was shown to provide real time imaging of prostate and surrounding tissues during RARP procedures using the da Vinci Surgical System. Intraoperative probe-based confocal laser endomicroscopy (pCLE) also known as optical biopsy was successfully performed in eight patients with no related complications. According to the study results, optical biopsy with Cellvizio was shown to enable stable microscopic visualization of a range of important surgical and oncologic landmarks including neurovascular bundles, which could help surgeons identify optimal nerve-sparing techniques for RARP.  Full Article

Mauna Kea Technologies SA Enters International Distribution Agreements for Cellvizio LAB Products
Thursday, 25 Jul 2013 11:45am EDT 

Mauna Kea Technologies SA announced that it has entered several distribution agreements for its line of Cellvizio LAB products, including the Cellvizio Dual Band, for pre-clinical research. According to the agreements, Quorum Technologies Inc., a North American company, will distribute the full range of Cellvizio LAB systems and products, including the Cellvizio Dual Band, to research laboratories in the United States and exclusively in Canada. The other new distributors of the Company's Cellvizio LAB products are Cold Spring Biotech Corp. in Taiwan; Crisel Instruments in Italy; Biotech Europe in Central and Eastern Europe; and Merkel Technologies in Israel.  Full Article

Mauna Kea Technologies SA Enters into Cellvizio Distribution Agreement with Japanese Medical Device Company
Thursday, 13 Jun 2013 11:45am EDT 

Mauna Kea Technologies SA announced that it has entered an exclusive distribution agreement in Japan with AMCO Inc. for a five-year period. This partnership aids the Company’s efforts to obtain regulatory approval in Japan. 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.  Full Article

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