A low-cost, ultra-widefield, nonmydriatic retinal imager for pediatric eye care and ROP screening

The National Eye Institute awarded Biolight Engineering LLC $906,443 on July 1, 2026, under the Vision Research program (CFDA 93.867) to develop and validate PedCAM, an ultra-widefield, nonmydriatic pediatric fundus camera for retinopathy of prematurity (ROP) screening and pediatric retinal disease diagnosis.

Biolight will finalize and fabricate five minimal viable product PedCAM systems incorporating pupil-matching control, adjustable illumination, autofocusing, and high dynamic range imaging. The company will conduct clinical validation at the University of Illinois Chicago, the University of Chicago, and Children's Hospital Los Angeles, collecting over 360 image sets from more than 180 patients to compare PedCAM performance against RetCam and traditional indirect ophthalmoscopy. The project also includes completion of safety testing and regulatory documentation.

The device addresses significant barriers in pediatric eye care: existing pediatric fundus cameras restrict field of view to 130 degrees, exceed $70,000 in cost, require pharmacologic pupil dilation, and adapt poorly to variable newborn ocular anatomy. PedCAM employs patented trans-pars-planar illumination to enable low-cost imaging with a 200-degree field of view without mydriasis, with preliminary studies demonstrating feasibility using handheld and smartphone-based prototypes.

Performance takes place in Hinsdale, Illinois. The project period runs from July 1, 2026, through May 31, 2028. Biolight collaborated with the University of Illinois Chicago, the University of Chicago, and Children's Hospital Los Angeles on the application.

Abstract

Biolight engineering LLC, in collaboration with the university of illinois chicago (UIC), the university of chicago and children's hospital LOS angeles, proposes to commercialize an ultra-widefield pediatric fundus camera (PEDCAM) for nonmydriatic imaging of retinopathy of prematurity (ROP) and other pediatric retinal diseases. Premature infants, comprising approximately 10% of newborns, are at risk for ROP, a leading cause of visual impairment and childhood blindness. Because ROP and related diseases often involve the peripheral retina, widefield fundus imaging is essential for diagnosis and management. However, existing pediatric fundus cameras suffer from significant limitations, including restricted field of view (≤130°), high cost (>$70,000), the need for pharmacologic pupil dilation, and poor adaptability to variable ocular anatomy in newborns. These barriers hinder access to timely eye care, especially in underserved and resource-limited regions. To address these challenges, we have developed PEDCAM, a novel imaging platform that employs patented trans-pars-planar illumination to enable low-cost, ultra-widefield (200°), nonmydriatic retinal imaging. Our preliminary studies have demonstrated feasibility using both handheld and smartphone-based PEDCAM prototypes, achieving full retinal coverage with high image fidelity. In this direct-to-phase II sbir project, we aim to (1) finalize and fabricate five minimal viable product (MVP) PEDCAM systems with integrated pupil-matching control, adjustable illumination, autofocusing, and HDR imaging; (2) validate clinical performance at UIC, the university of chicago, and children's hospital LOS angeles, collecting over 360 sets of images from more than 180 patients to compare PEDCAM with retcam and traditional indirect ophthalmoscopy; and (3) complete safety testing and regulatory documentation necessary for FDA 510(K) submission. In parallel, PEDCAM images will be evaluated for use in deep learning classification of ROP severity and plus disease, supporting future telemedicine deployment. The project's success criterion is submission of the 510(K) application by the project's conclusion. PEDCAM's low-cost (