The earlier amblyopia (lazy eye) and strabismus (misaligned eyes, eyes that don't track together) can be detected and treated, the better the outcome for the patient. Both of these conditions can affect vision, balance, and depth perception, and if left untreated can lead to permanent blindness. And while both amblyopia and strabismus are fairly common in children, impacting up to 5% of the population, most children do not routinely undergo visual screenings. While obvious cases of 'lazy' or misaligned eyes may be caught, these disorders are not always apparent to the observer, and without routine eye examinations up to 50% of these cases are missed in children.
REBIScan aims to bridge that gap with their Pediatric Vision Scanner (PVS): a handheld ocular scanning device that can detect both of these conditions. Additionally, early intervention and treatment may not just be more effective, but may also prove to save costs. According to REBIScan's website, "Researchers estimate that the direct cost of the conditions in America is over $1 billion per year. This is related to both missed diagnoses (leading to longer and costlier follow up examinations) and referrals of healthy children to specialists (resulting in wasted insurance...[spending]...and patient co-pays.) In America, approximately half of all cases are missed. Globally, it is estimated that 35-40 million children are affected by the condition." An easy-to-use device that streamlines improves the healthcare process and makes for better outcomes? Sounds like a win to me.
Recently approved via the de novo pathway, the PVS is roughly 94% effective at detecting these conditions in children. Per the de novo classification request "The Pediatric Vision Scanner is intended for the automated detection of misalignment of the visual axes using polarized light. It is indicated for the screening of amblyopia and micro strabismus associated with amblyopia in children age 2 to 8 undergoing evaluation in a professional eye care setting and who are responsive to taking direction and who can pay attention for at least 5 seconds."
FDA's Evaluation of Automatic Class III Designation (de novo request) is here.
Read REBIScan's press release here.