What You Should Know:
-Millions of Americans miss the simple screenings that could preserve their vision. identifeye HEALTH, a medical diagnostics company at the forefront of AI and automation, has officially launched its retinal screening platform and is now delivering results to patients through clinics and community programs.
-The compact, app-based system is now commercially available and FDA-registered and listed under a 510(k)-exempt classification.
identifeye HEALTH Launches FDA-Registered AI Retinal Imaging Platform to Expand Access to Eye Care
identifeye HEALTH is transforming access to vision care with a consumer-friendly retinal imaging platform powered by advanced AI and automation. Designed to bring screenings closer to patients, the solution streamlines workflow, reduces barriers to care, and enhances clinical efficiency. The company is backed by leading investors including Foresite Capital, Glenview Capital Management, and Hildred.
“For too long, patients—especially in rural and underserved communities—have lacked access to the screenings that could protect their sight and reveal broader health issues,” said Vicky Demas, CEO and founder of identifeye HEALTH. “This milestone is about more than technology. It’s about delivering answers earlier to the people who need them most.”
With FDA registration and listing secured, identifeye HEALTH has commenced U.S. commercial distribution. Pilot programs with major health systems and community-based providers are underway, enabling timely delivery of screening results at the point of care. The compact, app-based identifeye Camera allows nurses and medical assistants to capture high-quality retinal images with minimal training. Real-time guidance on alignment, focus, and image capture ensures consistent results with speed and accuracy.
Meeting an Urgent Public Health Need
More than 40% of Americans with diabetes miss their annual eye exams, leaving millions at risk of diabetic retinopathy—the leading cause of preventable blindness among working-age adults. The identifeye Camera is designed to reduce these gaps in care by addressing key barriers such as cost, time constraints, and lack of specialist access. With global diabetes rates projected to double by 2050, the urgency for accessible retinal screening has never been greater.
The platform incorporates automated features for image capture, workflow efficiency, and quality control. Clinical interpretation of results is currently performed remotely by teleretinal services providers. identifeye HEALTH is actively engaging with major health systems and community initiatives, including Remote Area Medical (RAM) in Ohio and Dare to C.A.R.E in Maryland, with additional partnerships expected in the near future.
