New product by Visibly approved by FDA for remote eyesight assessments

by | Aug 29, 2022

Visibly is a healthcare organization that resides in Chicago, US. The company was founded approximately ten years ago, with aspirations of breaking into the digital health industry through services orientated around eyesight and vision. Visibly offer a variety of services through their website such as a range of eyewear and contact lenses, in addition to a service that offers prescription renewal. For this service, visibly requires details from the customer’s eyecare provider including a doctor’s signature and the dates of the prescription, however, if this is not readily available the organization will contact the provider directly to improve the efficiency of their service.

The first of its kind

In August 2022, the United States Food and Drug Administration (FDA) has announced that they have granted Visibly with a 501k which will enable their new concept to reach the market lawfully. This stamp of approval from the FDA is imperative for a healthcare related product, as the organization oversees the maintenance of public health across the country and aims to develop the level of healthcare in the safest manner. The new product, named The Visible Digital Acuity Product, will allow eyesight screenings to be carried out on patients from the comfort of their own home. Patients will use their mobile device and are required to find ten feet of space in their residence to carry out testing. The test allows specialists to evaluate the vision of the patient from a distance and is complete within six minutes. The Visibly employee receives the results of the testing immediately and makes an evaluation on how the patient should proceed and what treatment is best suited to them. Visibly have stated that this form of digital testing is optimal for individuals whose current vision has not altered, and who require a new prescription or eyewear having already gone to an eyecare specialist prior to testing. The FDA made the decision to approve the product following a thorough study being carried out which displayed the superiority of the product, relative to a similar product belonging to ETDRS. The COO of Visibly, Paul Foley, commented on this stating the following; “Our Performance Data, including our prospective, multi-center 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.”

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