Visibly, the developer of an at-home digital vision testing platform, announced that it has received 510(k) clearance from the FDA for its Visibly Digital Acuity Product (VDAP). Visibly said it is the first FDA-cleared online visual acuity test on the US market.

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Visibly's telemedicine platform is designed to expand affordable access to vision care. 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. Users 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. The test is designed to be used by adults between the ages 22 to 40.

"After many years working with the FDA, we are excited to receive this clearance," Brent Rasmussen, CEO of Visibly, said in a company news rlease. "We look forward to fulfilling our mission of bringing affordable, accessible vision care to the masses."

"We are thrilled to achieve this milestone. Our performance data, including our prospective, multicenter 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," Paul Foley, Visibly's COO, said in the news release. "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 will continue to partner with 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.