identifeye HEALTH Launches FDA-Exempt Retinal Screening Platform, Expands Access to Vision-Saving Care

SAN FRANCISCO – August 20, 2025 — identifeye HEALTH, a medical diagnostics company specializing in AI-driven and automated screening, has officially launched its retinal screening platform in the U.S. The compact, app-based system is now FDA-registered and listed under a 510(k)-exempt classification and is being deployed through clinics, health systems, and community programs.

With its commercial rollout, identifeye HEALTH is delivering retinal screening results directly to patients and partnering with health systems, federally qualified health centers (FQHCs), and primary care providers to expand access. The company has also initiated pilot programs with organizations such as Remote Area Medical (RAM) in Ohio and Dare to C.A.R.E. in Maryland.

Addressing a Growing Need

More than 40% of Americans with diabetes do not receive annual eye exams, leaving millions at risk for diabetic retinopathy, the leading cause of preventable blindness among working-age adults. As global diabetes rates are projected to double by 2050, the need for accessible, affordable eye screening has become urgent.

The identifeye Camera is designed for point-of-care environments, enabling nurses and medical assistants to capture high-quality retinal images with minimal training. The platform uses real-time AI support to guide alignment, focus, and image capture, ensuring consistency and efficiency.

Streamlined Care Delivery

While the platform automates much of the workflow and image capture, clinical interpretation is currently performed remotely by teleretinal service providers. This approach reduces common barriers to screening—such as time, cost, and limited access to specialists—while enabling early detection and intervention.

“By making screenings easier to administer and more widely available, we’re tackling one of the biggest gaps in preventive care,” the company said in a statement.

Looking Beyond Eye Health

identifeye HEALTH’s long-term vision is to leverage the retina as a window into whole-body health. By expanding access to retinal imaging, the company aims to support broader preventive care efforts and more personalized approaches to population health management.