RetiVue EntireEye - A Handheld, High-Resolution, Non-Contact, One Image, Widefield Retinal Screening Camera for Premature and Healthy Newborn Babies

Project Summary Retinopathy of prematurity (ROP) is a treatable eye disease affecting the vision of over 28,000 premature ba- bies born in the US each year. More than 50,000 babies worldwide suffer blindness each year due to this dis- ease. Screening remains inadequate due to the low number of ophthalmologists trained for this and a lack of affordable and capable ROP screening equipment. Telemedicine based management of ROP could alleviate the burden of manual physician exam and ensure all infants receive timely screening. However, images from current technology often lack sufficient diagnostic quality and ease of use to replace expert physicians. To overcome this hurdle RetiVue L.L.C. has developed the RetiVue Entire Eye Portable, the most affordable, easy to use baby camera that provides the highest image quality with the widest field of view (FOV) of any portable device. We invented the first all-digital, no moving parts scanning light module to be used in a handheld widefield retina camera. Multiple spot beams illuminate the retina with light, while high speed pho- tography captures each spot beam, with these images then montaged into a seamless, high-quality, diagnostic ultra-widefield image. This technology once fully commercialized has the potential to screen the entire baby eye in one image. Overcoming the need to reposition the camera 10-15X, as required of current devices, and doing so at 1/5th the cost of the market leading baby cameras will help make worldwide premature baby screening a reality. Our proposed commercialization readiness pilot workplan will over the next 12 months transform our current prototype into a production device. We expect the final product to image up to 205° FOV in a single photo thru use of a digitally controlled 48 beam projector captured at 240 frames per second. This will provide non-con- tact, simplified, single image baby screening for ROP. This workplan is specifically focused on achieving cus- tomer identified metrics to ensure success in the marketplace including: 1) Wiring integration into a single USB-C cable from camera to laptop eliminating a 4 cable bulky harness. 2) Handpiece electronics integra- tion/space optimization reducing prototype length and weight by 30%. 3) Providing the user a WYSIWYG real- time, 48 beam montage and implementing automated image capture to improve camera operation. 4) In- creased visualization of retinal pathology through further improved illumination and AI enhancement of retinal vasculature. 5) Decreased build complexity of 48 beam scan projector to allow delivering a superior device at 1/5th the cost of competitors. 6) Externally validating that the device has improved sensitivity and specificity for detecting ROP compared to other baby cameras and direct physician exam.