Chicago-based health tech company Visibly’s digital acuity product (VDAP) has been approved by the US Food and Drug Administration (FDA) to become the first at-home digital vision testing platform in the US.
Visibly, formerly Opternative, had been forced by the FDA to recall its initial product in 2018 due to a lack of product safety and efficacy review and premarket approval prior to marketing. So the company is now thrilled with this result, said Visibly’s chief operating officer Paul Foley. “Our performance data, including our prospective, multicentre clinical study comparing VDAP to an ETDRS (considered the gold standard) visual acuity lane test, demonstrated VDAP’s safety and effectiveness are substantially equivalent to those of its predicate device.”
The technology requires a touchscreen mobile device to input responses, paired with a computer, displaying optotypes, to test how sharp a user's vision is. The test is designed for adults aged between 22 and 40 and takes about six minutes, with results sent to eyecare professionals to help them evaluate the best course of action for each patient, said the company.
“It will aid eyecare professionals in the remote evaluation of visual acuity and connect patients with care in a way that was not available before,” said Foley.
