Healthcare technology company Visibly has obtained CE mark approval for its Visibly Digital Acuity Product (VDAP) in the European Union (EU).
This approval indicates that VDAP meets the EU Medical Device Regulation (MDR) standards.
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Visibly’s online vision platform is designed to broaden the accessibility of vision care to millions of consumers by offering an affordable and convenient solution.
The test can be conducted using a combination of a touchscreen mobile device and a computer connected to the internet.
Visibly CEO Brent Rasmussen said: “These certifications are proof of the consistency and efficacy of Visibly’s online visual acuity test design and delivery processes. We are excited about the opportunities ahead and remain committed to increasing access to vision care solutions.”
In addition to the CE Mark approval, Visibly has been awarded the EN ISO 13485 certification.
With the CE mark approval and EN ISO 13485 certification, EU consumers will soon be able to access Visibly’s self-administered visual acuity test from the comfort of their homes.
Visibly plans to collaborate with optical organisations within the EU to provide eye care professionals with digital tools that can help extend their services to more patients.
Visibly regulatory affairs and quality assurance vice-president Michael Vader said: “The CE mark approval of VDAP in the EU marks the first significant step in expanding Visibly’s platform into the global marketplace, helping us achieve our goal of expanding affordable access.”
Founded in 2012 and based in Chicago, the company develops digital vision care solutions that empower patient choice and increase the capacity of providers.
