LOS ANGELES, November 28th, 2023 – Eyenuk, Inc., a leading global digital health company specializing in artificial intelligence (AI), today stands shoulder to shoulder with the National Eye Institute (NEI), U.S. Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) in championing the unified adoption of interoperable data standards for ocular image sharing among healthcare providers, researchers and patients.
The use of AI for the detection and monitoring of diseases from ocular imaging has the potential to dramatically improve patient access to care as well as advance diagnostic precision to levels exceeding current clinical assessments. However, a persistent industrywide challenge remains: Ocular imaging data collected using devices from different manufacturers are not standardized in a format that is seamlessly interoperable between diverse systems. The situation hampers opportunities for using AI to improve the quality, accessibility, and equitability of medical care. Moreover, it also hinders patients’ access to ocular imaging data, as required by the 21st Century Cures Act.
In a collective attempt to address this problem, the NEI, FDA, and ONC orchestrated a workshop in May 2022, inviting insights from industry leaders including Dr. Kaushal Solanki, the CEO and Founder of Eyenuk. The collaboration led the federal agencies this month to release a comprehensive roadmap to amplify the adoption of imaging standards, setting the stage for interoperability.
The roadmap calls for the agencies to build upon their synergistic efforts supporting adoption of the internationally recognized medical imaging standard DICOM (Digital Imaging and Communications in Medicine). Broadly, the NEI will encourage biomedical researchers to use ocular imaging data that conform to the DICOM standard; the FDA will continue to incentivize device manufacturers by allowing the use of the DICOM standard to meet certain premarket requirements and streamlining the approval process; and the ONC may require certified Electronic Health Records (EHRs) to support storing and accessing ocular imaging data that conform to the DICOM standard so that providers can quickly and easily view ocular imaging results for their patients.
Moreover, according to the roadmap, “The United States Department of Veterans Affairs and the Department of Defense will begin requiring full DICOM standardization for the PACS, imaging devices, and EHRs they use. This means that the country’s two largest integrated health care systems will see improved sharing, efficiency, and safety.”
Dr. Solanki, representing Eyenuk, remarked, “We are enthused by the federal initiatives to catalyze a unified approach to ocular imaging standards and interoperability. The industry-wide adoption of these standards is a crucial step enabling the use of AI to provide better care for patients. Universal adoption will propel groundbreaking research and enhance the efficiency, access, and level of patient care that can be provided.”
Eyenuk’s FDA-cleared EyeArt® AI system is the first and only autonomous AI system to receive FDA clearance for detecting both referable and vision-threatening diabetic retinopathy. This condition is the leading cause of blindness in working-age adults worldwide and often advances without noticeable symptoms. Early detection through EyeArt enables timely treatment, significantly lowering the risk of vision loss. Remarkably user-friendly, the EyeArt system is designed to be operated in the primary care setting by any individual with a high school diploma and produces actionable insights in less than 30 seconds.
The EyeArt technology presents a groundbreaking solution for increasing patient screening volumes. With its potential to serve as a precise and efficient point-of-care tool, it promises to expand access to screenings, benefiting both medical practices and patients alike.
About Eyenuk, Inc.
Eyenuk, Inc. is a global artificial intelligence (AI) digital health company and the leader in real-world AI Eye Screening™ for autonomous disease detection and AI Predictive Biomarkers™ for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk, and Alzheimer’s disease.
About the EyeArt AI System
The EyeArt AI system provides fully autonomous screening for diabetic retinopathy (DR), age-related macular degeneration (AMD), and glaucomatous optic nerve damage, including retinal imaging, based on international clinical standards and immediate reporting, in a single office visit during a patient’s regular exam. Once the patient’s fundus images have been captured and submitted to the EyeArt AI System, the detection results are available in a PDF report in less than 30 seconds.
The EyeArt AI system was developed with funding from the U.S. National Institutes of Health and is validated by the U.K. National Health Service. The EyeArt AI system has CE marking as a class IIb medical device in the European Union under the EU’s Medical Devices Regulation 2017/745 (“MDR”) for the detection of DR, AMD, and glaucomatous optic nerve damage. Additionally, the system has U.S. Food and Drug Administration 510(k) clearance and a Health Canada license for autonomous detection of DR. It is designed to be General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant.
The EyeArt AI system is reimbursable by government and private payors in the U.S. under the Category 1 Current Procedural Terminology (CPT) code 92229.