Online eyewear and vision care business Visibly announced that he had received 510(k) clearance from the FDA for his home vision test.
The Visibly Digital Acuity product uses a touchscreen mobile device, such as a smartphone, paired with a computer to test the visual acuity or sharpness of vision of a remote user.
The computer screen displays optotypes, or specifically shaped symbols or letters for vision testing, while the mobile device serves as a controller where users can enter their answers. The test is designed for use by adults between the ages of 22 and 40.
Obviously said the test usually takes about six minutes. The results are then sent to eye care professionals who can help users determine how users should proceed.
“We are delighted to have reached this milestone. Our performance data, including our multi-center prospective clinical study that evaluated the safety and efficacy of VDAP versus an ETDRS visual acuity test, demonstrated that the “VDAP’s safety and efficacy are substantially equivalent to those of its predicate device,” said Paul Foley, chief operating officer of Visibly, in a statement.
“The clinical performance of the VDAP will help eye care professionals assess visual acuity remotely and connect patients to care in a way not previously available.”
THE GREAT TREND
Founded in 2012 under the name Opternative, the company recently raised $9 million in funding in 2018. According to Crunchbase, Visibly’s total raise is $18.5 million.
This launched an online refractive eye exam in 2015, aimed at helping users determine their eyeglass or contact prescription. The tests were rejected by the American Optometric Association, which wrote a letter to the FDA saying the agency should regulate Optative more strictly.
The company then received a warning letter from the FDA stating that the online eye test required pre-marketing clearance as a class 2 medical device. At the time, Opticative said MobiHealthNews he was “working closely” with the agency to resolve the issue. In 2019, the refractive eye exam was recalled.
“After many years of working with the FDA, we are delighted to receive this clearance,” Visibly CEO Brent Rasmussen said in a statement. “We look forward to fulfilling our mission to bring affordable and accessible vision care to as many people as possible.”