Medical device and MedTech insights, news, tips and more

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

Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.

We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.

Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.

More insights

March 7, 2024
FDA Clears Dexcom’s First Over-the-Counter Continuous Glucose Monitor
Learn More
March 1, 2024
FDA greenlights Boston Scientific’s Novel Drug-Coated Balloon for Coronary In-Stent Restenosis
Learn More
February 21, 2024
Sparrow BioAcoustics Launches Software That Turns a Smartphone into a Stethoscope 
Learn More

Begin your legacy now. We are your medtech and medical device talent advisory firm.