Visibly, the developer of an at-home digital vision testing platform, has received 510(k) clearance from the FDA for its Visibly Digital Acuity Product (VDAP). Visibly is the first FDA-cleared online visual acuity test on the US market.
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.
The test can be taken at any time, and the total process takes about 6 minutes. Professionals in eye care are quickly and securely given access to the full findings of the vision test, assisting them in determining the best course of action for each patient. The test can 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."
In order to provide eye care professionals and their patients with a practical and cheap approach to learn about people's vision from the comfort of their own homes, Visibly will keep working with optical organizations.