Recent MDR certification of Navilas® underlines its advanced standard in retina lasers and opens path to new developments

Home Recent MDR certification of Navilas® underlines its advanced standard in retina lasers and opens path to new developments
Written by Doug Hampton
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Booth C328 ESCRS – Masterclass on contact-free treatments of peripheral tears will showcase easy to control retinal laser care with an image-guided platform beyond slit-lamp lasers

TELTOW, Germany, Sept. 7, 2023 /PRNewswire/ — Just in time for the ESCRS conference taking place Sep 8-11, 2023 in Vienna, OD-OS GmbH is announcing that its Quality Management System and the Navilas® Laser System 577s have been certified in accordance with the Medical Devices Regulation (EU) 2017/745 (EU MDR). Navilas® is one of the first laser products for medical retina to achieve certification according to new MDR standards. The only navigated retina laser with integrated eye tracking technology is a step beyond traditional slit-lamp lasers. It is transforming posterior pole laser care thanks to enhanced precision, speed and digital integration paving the way to further standardization and automation. The 577nm yellow laser also includes a subthreshold microsecond pulsing and an anterior treatment mode.

– Picture is available at AP –

Dr. Winfried Teiwes, Managing Director, OD-OS GmbH: “We are very proud to have passed this important quality review of our processes and products. This confirms the high standards of our image-guided laser platform and enables us to develop future solutions to treat retinal diseases based on our unique navigation technology. We will continue to provide patients and our users in clinics and practices with more comfortable, minimally invasive and easy to control laser care.”

At ESCRS in Vienna, Navilas® treatments can be observed at OD-OS booth C328. In a masterclass on Sunday, Sep 10 at 11:00 am, the unique principle of non-contact peripheral tear treatments will be presented in a special session for booth visitors.

In many clinics, retinal laser is still performed with manually operated single spot or multi-spot laser systems which only provide a small slit lamp view on the retina. The high-resolution fundus image of the Navilas® Laser System provides better overview during treatment. Caution zones on sensible areas like the fovea and the optic disk combined with the integrated eye tracking allow for tracked and therefore highly precise lasering. As a result, over the past years navigated laser technology has been adopted by leading institutions in more than 40 countries around the world. Watch video: http://www.od-os.com/navilas-laser-system

Navilas® supports laser retinopexy and panretinal photocoagulation with uniform spot distribution which has been found to be faster and less painful for patients than PRP treatment with conventional slit-lamp lasers. Microaneurysms are more precisely targeted with computer assisted lasering. The yellow laser with 577nm wavelength also supports tissue-friendly microsecond pulsing applications and has an anterior treatment mode.  www.od-os.com/publications

About: OD-OS GmbH is a medical device company founded in 2008 with offices in Teltow, Germany, and Irvine, CA. www.od-os.com

For further information, please contact: Stefanie Gehrke, Director Sales and Marketing | [email protected], +49 (172) 3808 537
OD-OS GmbH | Warthestr. 21 | 14513 Teltow | Germany

SOURCE OD-OS GmbH

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