Online eyewear and vision care company Visibly announced it had received FDA 510(k) clearance for its at-home vision test.
The Visibly Digital Acuity Product uses a touchscreen mobile device, like a smartphone, paired with a computer to test visual acuity, or how sharp a user's vision is at a distance.
The computer screen displays optotypes, or specifically shaped symbols or letters for vision...
In early August, the FDA issued a Class 2 Device Recall for Visibly’s Online Refraction Vision Test, stating that the company did not receive authorization from the FDA to market the product. According to the recall, Visibly has already initiated the recall.
This back and forth between the Chicago-based startup (formerly known as Opternative) and the FDA has been going on for a couple of years....
Online refractive eye exam company Visibly, formerly called Opternative, has filed a complaint in Indiana seeking to overturn a law prohibiting providers from prescribing corrective lenses via telemedicine in the state.
The suit, filed in Indiana’s Marion County Superior Court, names The Medical Licensing Board of Indiana and the Indiana Professional Licensing Agency, as well as several...
