Visibly, the developer of the world’s first at-home digital vision testing platform, is excited to announce that, as of August 12, 2022, it has received 510(k) Clearance from the United States Food and Drug Administration for its Visibly Digital Acuity Product (VDAP). Visibly becomes the first FDA-cleared online visual acuity test on the US market.
With their newly-acquired 510(k) Clearance from the FDA, Visibly’s telemedicine platform can continue to expand affordable access to vision care for millions of consumers. Consumers can access Visibly’s on-demand, self-administered visual acuity test using a combination of a touchscreen mobile device and computer connected to the internet. Consumers can take the test at any time and complete the entire experience in about 6 minutes. Completed vision test results are made available to Eye Care Professionals immediately and securely, helping them evaluate the best course of action for each patient.
“After many years working with the FDA, we are excited to receive this clearance …”, says Brent Rasmussen, CEO of Visibly. “…We look forward to fulfilling our mission of bringing affordable, accessible vision care to the masses.”
Visibly will continue to offer a convenient, affordable way to assess vision at home.
Paul Foley, Visibly’s COO, commented, “We are thrilled to achieve this milestone. Our Performance Data, including our prospective, multi-center clinical study that evaluated the safety and effectiveness of VDAP compared to an ETDRS Visual Acuity Lane Test, demonstrated that the safety and effectiveness of VDAP are substantially equivalent to those of its predicate device. VDAP’s clinical performance will aid Eye Care Professionals in the remote evaluation of visual acuity and connect patients with care in a way that was not available before.”
Visibly is eager to accelerate its mission to partner with the leading optical organizations to equip Eye Care Professionals and their patients with a convenient and affordable way to get information about how well people are seeing from their own homes.
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.