August 24, 2022
Online vision testing provider Visibly received 510(k) clearance from the United States Food and Drug Administration (FDA) on Aug. 12, 2022 for its Visibly Digital Acuity Product (VDAP), making it the first FDA-cleared online visual acuity test on the U.S. market, according to reporting by Vision Monday.
“After many years working with the FDA, we are excited to receive this clearance,” said Brent Rasmussen, CEO of Visibly. “We look forward to fulfilling our mission of bringing affordable, accessible vision care to the masses.”
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 eyecare professionals in the remote evaluation of visual acuity and connect patients with care in a way that was not available before.”
Visibly’s on-demand, self-administered visual acuity test enables consumers to renew their eyeglass or contact lens prescription online. Consumers can access the test on Visibly’s website using a combination of a touch screen mobile device and computer connected to the internet. Consumers can take the test at any time and complete the entire experience in about six minutes, according to Visibly.
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Completed vision test results are made available to eyecare professionals immediately and securely, helping them evaluate the best course of action for each patient. About 35 percent of patients who take the test are referred to local optometrists or ophthalmologists for follow-up care, Rasmussen told VMAIL. The test is currently available in 40 states, he said.
Rasmussen said he wants to add a complete, online refraction test to Visibly’s product mix. Visibly had previously marketed the refraction test to consumers before it was recalled by FDA in 2019. The company plans to file a De Novo classification request with FDA for the refraction test, which operates on the same platform as Visibly’s visual acuity test. The De Novo request provides a marketing pathway for novel medical devices that FDA considers to be safe and effective for their intended use.
