identifeye HEALTH launches retinal screening platform

Demonstration of the identifeye HEALTH device in use.

Photo owned by identifeye HEALTH and used with permission

identifeye HEALTH has launched its retinal screening platform and is now delivering results to patients through clinics and community programs. The platform is a compact, app-based system that is FDA-registered under a 510(k)-exempt classification. Under the FDA 510(k)-exempt classification, identifeye HEALTH is now a registered medical device company.¹

With this FDA registration, identifeye HEALTH has begun commercial distribution in the US. The company is initiating pilot programs with health systems and community-based providers. The system is designed for point-of-care environments, allowing nurses and medical assistants to capture high-quality retinal images with minimal training. The company has stated that the identifeye Camera can help to lower common barriers to screening, including time constraints, cost, and limited specialist availability.¹

The platform provides real-time assistance with alignment, focus, and image capture to ensure speed, consistency, and quality.¹

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. It is now live in pilot programs with several health systems and community screening initiatives, including Remote Area Medical (RAM) in Ohio, Dare to C.A.R.E in Maryland, with more expected in the coming months.¹

Photo of Vicky Demas, CEO of identifeye HEALTH, used with permission

With the announcement of this news, Ophthalmology Times had the opportunity to speak with Vicky Demas, CEO of identifeye HEALTH to discuss how this advancement in technology can benefit patients and ophthalmologists. Demas is an engineer by training who has spent the last 25 years working at the conjunction of technology and healthcare. Notably, she was a part of the team at Google X working on their life sciences initiatives. Demas noted that this role was "when I was introduced to the concept of the eye as a window into the body and health, and the potential of the platform to really not only look at ophthalmic diseases in the retina, but also systemic disease in a very scalable way.”

Speaking to the mission of identifeye HEALTH and the goal of screening patients whose vision might otherwise go unchecked, Demas said, “We're partnering with great organizations, returning results to patients who otherwise wouldn't have been able to get their vision checked. We're super excited to be making impact learning from the field and figure out how we can make this a scalable solution.”

Demas also noted that the goal is to aid ophthalmologists in seeing the patients who most urgently need their vision cared for. She said, “Our general approach, is that we're really looking to figure out how to integrate into workflows and help triage patients to specialty care as they're needed, not to substitute, but to make it accessible. We want to figure out how to make sure that patients who should see an ophthalmologist see an ophthalmologist, and those who don't, don't bottleneck the system, don't get inconvenienced, etc.”

Look for the full interview on Ophthalmology Times soon.

Reference:

1. identifeye HEALTH Launches FDA-Exempt Retinal Screening Platform, Now Delivering Results to Patients. Identifyee HEALTH. News Release. August 20, 2025. Accessed August 20, 2025. https://firstwordhealthtech.com/story/5991018#:~:text=Millions%20of%20Americans%20miss%20the,through%20clinics%20and%20community%20programs.