• identifeye HEALTH’s flagship device automates retinal imaging, paving the way for screening, monitoring, and wellness products
• Among the first to automate the end-to-end workflow process, the camera marks a significant advancement in increasing accessibility and efficiency for high-quality retinal imaging
• The retina, one of the few places in the body where nerves and blood vessels can be directly visualized, offers insights into systemic conditions such as diabetes, hypertension, cardiovascular disease, and neurological health. 

identifeye HEALTH, a medical diagnostics company at the forefront of AI and automation, is proud to announce the launch of the identifeye System, a retinal imaging camera designed to bring retinal imaging in settings closer to the patient. The product will be available in the coming months following the use of the device in clinical trial settings. 

Traditionally, eye screenings are conducted by specialists in dedicated eye care centers. However, with only 39% of the U.S. population visiting an optometrist annually, identifeye HEALTH is on a mission to make vision care more accessible. The identifeye System is designed to seamlessly integrate into routine health screenings, allowing healthcare professionals to conduct retinal imaging alongside standard physical exams and vital checks in their offices.

The identifeye team brings a consumer-centric approach to medical device development, creating tools that are not only robust and reliable but also user-friendly and intuitive. Their flagship product, the identifeye System, leverages automation to make high-resolution retinal imaging accessible at scale. By simplifying complex tasks—such as manual adjustments, alignment with the patient's pupil, and ensuring the appropriate field of view—the system overcomes traditional challenges existing fundus cameras face. With minimal training required, busy healthcare professionals, including medical assistants, can easily perform retinal imaging in point-of-care and general practice environments.

The identifeye System stands out for its intuitive design and advanced features:

• User-friendly interface: Operated through a simple, intuitive app, making it accessible for all healthcare professionals.
• AI-driven automation: Automates complex tasks, including adjusting settings and managing image capture during patient blinks, ensuring high-quality results every time.
• Portability and convenience: The compact, foldable, battery-operated design makes it easy to use and transport, bringing retinal imaging closer to patients.
• Full stack integration: Controlling the full stack allows for more flexibility to explore the solution space while continuing to improve.

identifeye HEALTH is leveraging AI to unlock new diagnostic potential from retinal images, aiming to establish the retina as a key non-invasive diagnostic platform. The retina, one of the few places in the body where blood vessels can be directly visualized, offers insights into systemic conditions such as diabetes, hypertension, and cardiovascular disease. Changes in the retinal nerve fiber layer can also provide critical information about neurological health, potentially aiding in the early detection of disorders like multiple sclerosis and Alzheimer's. With AI, these insights can be harnessed to tackle some of the most significant health challenges of our time.

identifeye HEALTH's current focus is on diabetic retinopathy (DR), the leading cause of preventable blindness among American adults of working age. Despite recommendations for annual eye exams, nearly 40% of diabetics do not receive these crucial screenings, often due to socioeconomic barriers. The identifeye System, combined with AI-enhanced diabetic retinopathy screening tools currently in development, aims to bridge this gap, making retinal screenings a routine part of annual physical exams. Non-invasive retinal imaging readily identifies the early signs of vision loss and significantly changes outcomes for diabetic retinopathy, which remains undetected in its earliest stages.

Vicky Demas, CEO of identifeye HEALTH, brings over 25 years of experience building teams and launching transformative products in the healthcare industry. As a founding member of Google Life Sciences (now Verily), Vicky was pivotal in building multidisciplinary science and engineering programs, leading to groundbreaking advancements in AI, diagnostics, and medical devices. After contributing significantly to the development of the multi-cancer early detection test at GRAIL, Vicky joined and rebranded Tesseract to identifeye HEALTH. She is now leading the charge to democratize access to retinal imaging, leveraging AI and automation to unlock the retina's potential as a powerful diagnostic and wellness platform.

"Many individuals at risk for conditions like diabetic retinopathy do not receive the necessary eye exams due to accessibility issues," said Demas. “Our goal with the identifeye System is to bridge this gap by bringing advanced retinal imaging to more accessible settings and developing AI tools that will ultimately improve disease monitoring and patient outcomes. The eyes aren't just windows to the soul; they're windows to our health.”

The identifeye System has the capability to support the early detection and management of a wide range of conditions beyond diabetic retinopathy, including neurological, inflammatory, and cardiovascular diseases. With commercialization plans underway, identifeye HEALTH has recently completed an eight-site study to advance its algorithm development and is preparing for a validation study. The company plans to begin providing the identifeye System to qualified healthcare practitioners in the coming months, with full commercialization anticipated in early 2025.