Latest News - CE Mark Approval

Wednesday, May 31, 2017 | CE Mark Approval

Implandata's Eyemate System for Improved Monitoring and Management of Glaucoma Patients Receives CE Mark

Implandata’s Eyemate system for enhanced monitoring and care of glaucoma patients has attained CE certification and is available for commercial use within the European Union. The system was deve…

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Thursday, May 11, 2017 | CE Mark Approval, STAAR Surgical

Staar Surgical Announces CE Mark Approval for the EVO+ Visian ICL with Aspheric (EDOF) Optic

Staar Surgical has received CE Mark for its EVO+ Visian ICL with Aspheric (EDOF) Optic. The EDOF Optic is surgically implanted and works in harmony with the patient's eye to correct vision. Unlike…

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Saturday, May 06, 2017 | CE Mark Approval, OPHTEC

Ophtec Receives CE-Mark for Precizon Presbyopic Aspheric Presbyopia-Correcting IOL

Ophtec announced that it has received CE-Mark for a new aspheric presbyopia-correcting IOL, Precizon Presbyopic, with an innovative patent pending continuous transitional focus (CTF) optical design. …

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Tuesday, March 21, 2017 | CE Mark Approval

Sanoculis Receives CE Mark for its Minimally Invasive Micro Sclerostomy (MIMS) Device

Sanoculis has announced that its minimally invasive micro sclerostomy (MIMS) device and procedure has been granted the CE marking, enabling market launch in Europe. Sanoculis now plans to conduct a la…

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Wednesday, October 12, 2016 | CE Mark Approval

Optotek Medical’s OptoSLT Nano Laser Receives CE Mark Approval

Optotek Medical announced that its newest laser, the OptoSLT Nano, has received CE Mark approval and is now commercially available. The receipt of CE mark approval makes the OptoSLT Nano the first 1 n…

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Friday, September 09, 2016 | CE Mark Approval, Glaucoma

Sight Sciences Announces CE Mark Approval of the VISCO 360 Viscosurgical System for the Surgical Treatment of Glaucoma

Sight Sciences announced that the initial European commercial cases with the CE mark approved VISCO 360 Viscosurgical System will be presented September 12 during the European Society of Cataract and …

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Monday, August 01, 2016 | CE Mark Approval, Pixium Vision

Pixium Vision Receives CE Mark Approval of IRIS II Bionic Vision System

Pixium Vision announced that it has been awarded the CE mark for its IRIS II bionic vision system, indicated for people with vision loss from outer retinal degeneration. The 150-electrode epiretinal i…

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Wednesday, June 29, 2016 | CE Mark Approval, Product Releases

Eyenuk Announces CE Mark and Commercial Launch of EyeArt 2.0 Automated Diabetic Retinopathy Screening Software

Eyenuk announced receipt of the CE Mark and the launch of the second generation of its EyeArt fully automated diabetic retinopathy (DR) screening software. The company plans to roll out EyeArt 2.0 to …

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Wednesday, May 11, 2016 | CE Mark Approval, OASIS Medical

CE Mark Available for Soft Shield Collagen Shields Through Oasis Medical

Oasis Medical has obtained a CE Mark for their Soft Shield collagen corneal shields, which allow for ocular healing to take place by providing a protective barrier over the surface of the eye. As the …

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Monday, May 02, 2016 | CE Mark Approval, Product Releases, , Carl Zeiss Meditec

Zeiss Receives CE Mark Approval for PLEX Elite 9000 Swept-Source OCT

Zeiss announced that it has received CE Mark approval for its new swept-source OCT technology platform, Zeiss PLEX Elite 9000. The new platform expands researchers’ ability to examine the cr…

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Monday, April 04, 2016 | CE Mark Approval

Visunex Medical Systems Receives CE Mark for the Panocam LT System

Visunex Medical Systems announced that it has received CE Mark for the Panocam LT Wide-field Imaging System, a compact, wireless imaging system that is designed to detect a number of external, anterio…

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Tuesday, February 16, 2016 | CE Mark Approval, IRIDEX

Iridex Receives CE Mark for Cyclo G6 Laser System for the Treatment of Multiple Stages of Glaucoma

Iridex announced it has received CE Mark to commercialize across Europe the Cyclo G6, its first laser system designed solely for use in treating glaucoma and its symptoms. The Cyclo G6 laser system is…

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Friday, December 25, 2015 | CE Mark Approval, Avedro

Avedro Announces CE Mark Clearance for its Mosaic Advanced Cross‐Linking System and CEO Transition

Avedro announced that it has received the CE Mark for its Mosaic system, a device that has the potential for nonsurgical improvement for low myopia with a procedure called PiXL (Photorefractive Intras…

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Monday, October 05, 2015 | CE Mark Approval

ClarVista Harmoni Receives CE Mark for Europe

ClarVista Medical announced it has received CE Mark of the Harmoni Modular IOL System for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. The un…

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Tuesday, September 22, 2015 | CE Mark Approval

MacuLogix Receives CE Mark for AdaptDx

MacuLogix announced that it has completed the requirements for CE marking of the AdaptDx, the first instrument to provide a practical and objective measurement of dark adaptation function, according t…

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