Visibly Achieves International Milestone with CE Mark Approval in the European Union (EU)
CHICAGO, Sept. 18, 2024 /PRNewswire/ — Visibly, a leader in vision care innovation and the developer of the world’s first FDA-cleared online visual acuity test, is thrilled to announce that their Visibly Digital Acuity Product (VDAP) has received CE Mark Approval in the European Union (EU), demonstrating compliance with the EU Medical Device Regulation (MDR).
Additionally, Visibly received the EN ISO 13485 certification, further demonstrating Visibly’s commitment to innovation and quality products designed for effective vision care. This international standard ensures consistency and efficacy of medical devices’ design, development, production, and delivery processes, signifying they are safe for their intended purpose.
“These significant milestones are a testament to the dedication the Visibly team has shown in expanding safe and effective vision care services to consumers. 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,” commented Michael B. Vader, Vice President of Regulatory Affairs and Quality Assurance at Visibly, Inc.
Visibly’s online vision platform continues to expand affordable access to vision care for millions of consumers. With CE Mark Approval of VDAP and EN ISO 13485 certification of the Quality Management System, consumers in the EU will soon have access to Visibly’s on-demand, self-administered visual acuity test conveniently from their home using a combination of a touchscreen mobile device and computer connected to the internet. To learn more about the Visibly visual acuity test and portfolio of products, visit the Visibly website.
“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,” commented Brent Rasmussen, CEO of Visibly.
Visibly is looking forward to partnering with leading EU optical organizations to equip eye care professionals with digital solutions to expand their patient reach.
ABOUT VISIBLY
Visibly is a Chicago-based healthcare technology company founded in 2012, building digital vision care solutions that enable patient choice and provider capacity. Online vision testing is just the start; Visibly envisions a world where technology enables patients and doctors to connect easily and make other aspects of vision care more convenient and accessible to everyone.
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SOURCE Visibly
