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eSight 4 Earns CE Mark Approval to Bring New Wearable Device to Europe
August 10, 2020
eSight, a cutting-edge vision enhancement platform, today announces it has received CE Mark approval for eSight 4, the company’s latest assistive technology device that’s clinically proven to significantly enhance vision for those living with low vision and legal blindness. The CE Mark certification signifies that eSight 4 has been assessed to meet high safety, health and environmental protection requirements in Europe and is considered an essential requirement for companies to sell and distribute medical products within the European Economic Area (EEA). There are an estimated 30 million people who are blind or partially sighted according to the Voice of Partially Sighted and Blind People of Europe.
“Having launched eSight 4 in North America just last month, we’re already seeing interest on a global level,” said Robert Vaters, eSight’s CEO and President. “The CE Mark is an important milestone for the company as it brings us one step closer to worldwide availability. With shipping slated to begin this Fall, European residents will have the opportunity to see new possibilities through eSight 4’s advanced, yet easy-to-use, technology.”
The device works by combining a best-match camera and lens technology with advanced sensors and proprietary algorithms to maximize the quality of information sent to the brain, which in turn dramatically augments sight. Wireless with built-in vision controls, the eSight 4 headset features an ergonomically designed halo band with a rechargeable battery that can be replaced within seconds for all-day comfort and use. eSight 4 is also cloud-based, so wearers are provided with easy and instant access to the latest features and invite loved ones and eSight support members to see what they are seeing and help manage their eSight experience. Other key features of the device include advanced controls, allowing the user to control their vision with 24x zoom and a unique, patented bioptic tilt to maintain use of natural peripheral vision, and a new Apple® and Android® mobile apps that make it easier for people with low vision to see their smartphone screen in detail and watch content.
The device works for those living with visual acuities from 20/60 to 20/1400 (perfect vision is 20/20) caused by more than 20 different eye conditions including macular degeneration, diabetic retinopathy and Stargardt’s disease. To date, thousands of people globally have benefited from various iterations of the device.
The CE Mark is eSight’s latest global credential, as the technological approach has also been clinically-validated by a multicenter prospective cohort study (eQUEST) for users aged 13 to 75. In Canada, eSight Corporation is on the FDA and EUDAMED lists and inspected by Health Canada. Additionally, eSight is a Class I medical device in North America and the European Union.
See Full Press Release at the Source: eSight 4 Earns CE Mark Approval to Bring New Wearable Device to Europe
Press Release by: eSight Eyewear
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