Online eye and vision care company Visible notice it has been received FDA License 510(k) for home vision testing.
A visible digital Acuity product that uses a mobile device with a touch screen, such as a smartphone, paired with a computer for testing eye sightor how far away the user’s field of vision is.
The computer screen displays optotypes, or specifically shaped symbols or letters for the vision test, while the mobile device acts as a controller where the user can enter answers their. 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 the user determine how the user should proceed.
“We are delighted to have reached this important milestone. Our performance data, including our prospective, multicenter clinical study evaluating the safety and efficacy of VDAP compared with ETDRS’ visual lane test has demonstrated that VDAP’s safety and effectiveness are essentially equivalent for its predicate devices,” Paul Foley, COO of Visibly, said in a statement.
“VDAP’s clinical performance will assist eye care professionals in remote vision assessment and connect patients to care in a way that has not been possible before.”
TREND TO BIGGER
Established in 2012 as Optnativecompany with the most recent salary increase 9 million dollars in funding in 2018. According to CrunchbaseVisible’s total raised is $18.5 million.
It Launching online refractive eye exam in 2015, to help users identify prescriptions for their glasses or contact lenses. Tests get feedback from the American Optometric Association, wrote a letter to the FDA arguing that the agency should more closely regulate Opternative.
The company then received a warning letter from FDA say online eye exam Mandatory pre-market authorization as a Class 2 medical device. At the time, the Opternative told MobiHealthNews it was “working closely” with the agency to resolve the issue. In 2019, eye refraction examination was called back.
ON PROFILE
“After many years of working with the FDA, we are delighted to receive this authorization,” Visibly CEO Brent Rasmussen said in a statement. “We look forward to fulfilling our mission of bringing affordable, accessible vision care to the public.”
