Dive Brief:
- Visibly has received 510(k) clearance from the Food and Drug Administration for an on-demand, self-administered visual acuity test that lets consumers check their vision online.
- The device, which Visibly said is the first FDA-cleared online visual acuity test on the U.S. market, uses a touchscreen mobile device and a computer connected to the internet to assess vision.
- In clearing the test, the agency has placed restrictions on its use, limiting it to adults aged 22 to 40 years and cautioning that it only gives “supportive recommendations” and “does not replace an eye health exam with a licensed provider.”
Dive Insight:
People who sign up to take Visibly’s online vision test need 10 feet of space; a mobile device, computer, or tablet display; and the prescription for their current correction. Visibly says the test is best suited to people whose vision has not changed, who have recently completed a comprehensive eye exam and are looking to renew an expired prescription, or buy glasses or contacts.
The test takes about six minutes to complete and 90% of prescriptions are issued within 24 hours, according to Visibly. A licensed doctor in the same state as the consumer reviews the results of online tests. If a person’s vision has changed, Visibly will not renew the prescription. Rather, the company will advise the individual to see an in-person doctor.
Visibly secured the 510(k) clearance after running a prospective, multi-center clinical study that evaluated the safety and effectiveness of its online system against an ETDRS Visual Acuity Lane Test. The trial found the safety and effectiveness of the online test are substantially equivalent to the standard eye test.
Visibly CEO Brent Rasmussen said in a statement that the clearance followed “many years working with the FDA.” Visibly, which was founded in 2012, submitted its 510(k) filing in January and received approval last week.
