NovaSight Gains 510(k) Clearance for CureSight
NovaSight received 510(k) clearance from the FDA for its CureSight digital therapy device for treatment of amblyopia, also known as lazy eye.
The eye-tracking system trains users as they watch streamed video content of choice through red-blue treatment glasses.
CureSight blurs the center of vision of the image that is shown to the strong eye using real-time image processing, which encourages the brain to complete the image's fine details from the lazy eye image and trains the two eyes to work as a team.
The FDA clearance was based on positive results from a clinical trial, which showed the digital therapy was noninferior to using a patch.