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.
“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 its platform now registered and listed with the FDA, identifeye HEALTH has commenced commercial distribution in the U.S. The company is initiating pilot programs with leading health systems and community-based providers, enabling the delivery of retinal screening results to patients, in alignment with the platform's intended use. Designed for point-of-care environments, the compact, app-based system allows nurses and medical assistants to capture high-quality retinal images with minimal training. The platform provides real-time assistance with alignment, focus, and image capture to ensure speed, consistency, and quality.
More than 40% of Americans with diabetes in the U.S. miss their annual eye exams, leaving millions vulnerable to diabetic retinopathy, the leading cause of preventable blindness among working-age adults. Designed for ease of use, the identifeye Camera helps lower common barriers to screening, including time constraints, cost, and limited specialist availability. With global diabetes rates expected to double by 2050, expanding access to screening is more urgent than ever.
“Contributing to the development of the identifeye Camera from a clinician's perspective has been a deeply rewarding experience,” said Dr. J. Rocco Robilotto, co-founder of Eye Associates of New York and the Center for Ophthalmic and Vision Research. “What makes this device truly stand out is how easy it is to use, even with minimal training. Frontline staff can operate it in community-based settings, closer to the patients who need it most. With features like multilingual instructions, it's designed to be inclusive and adaptable. It's inspiring to see this kind of technology making its way into communities that for too long have had limited access to comprehensive eye care.”
The identifeye HEALTH platform incorporates automated features to streamline workflow, image capture, and quality assessment, while clinical interpretation of results is currently performed remotely by a teleretinal services provider. identifeye is now in active discussions with major health systems and providers to pursue pilots as well as community screening initiatives, including Remote Area Medical (RAM) in Ohio and Dare to C.A.R.E in Maryland, with more expected in the coming months.
“The Heart Health Foundation has been thrilled to work with the identifeye team and join others in bringing critical diagnostic gaps in underserved communities. Its ease of use and accessibility allow us to add high-quality retinal screenings directly at the point of care, bringing life-saving diagnostics to patients who might otherwise go without. It is a powerful addition to our heart and vascular screening program, and I am excited by its potential to transform access nationwide,” said Dr. John Martin, MD, MBA, FACS, President of the Heart Health Foundation and its award-winning Dare to CARE program.
With this U.S. launch, identifeye HEALTH is taking its first step toward a broader vision: using the retina as a window into whole-body health. By expanding access to high-quality retinal imaging, the company aims to support more personalized and preventive care for all.
If you're interested in partnering with identifeye HEALTH to bring AI-powered retinal screening to your community, visit https://www.identifeye.health/contact
Disclaimer: The identifeye Camera is intended solely for the capture and storage of images of the eye and surrounding area. Interpretation of images and delivery of screening results are performed by qualified clinicians.
About identifeye HEALTH
identifeye HEALTH is dedicated to making retinal imaging accessible and equitable through the development of intuitive, consumer-friendly platforms that utilizes advanced AI and automation. By bringing care closer to patients, identifeye HEALTH aims to enhance efficiency and improve patient outcomes. The company's investors include Foresite Capital, Glenview Capital Management, Hildred, and more.
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