Product Overview: IDx-DR
What is IDx-DR?
IDx-DR is a groundbreaking, autonomous Artificial Intelligence (AI) system designed for the early detection and automated diagnosis of Diabetic Retinopathy (DR). It is the first and only AI system of its kind to receive authorization from the FDA and to be CE marked, making it a pioneering tool in the field of ophthalmology.
Key Features
- Autonomous AI Technology: IDx-DR uses advanced AI algorithms to analyze retinal images, eliminating the need for a clinician to interpret the images or results. This makes it accessible for use by healthcare providers who may not have specialized training in eye care.
- Detection Capability: The system is specifically designed to detect more than mild diabetic retinopathy (mtmDR) in adults over 22 years old who have been diagnosed with diabetes but have not previously been diagnosed with DR. It can also identify macular edema, a complication associated with diabetic retinopathy.
- Image Acquisition and Analysis: IDx-DR operates using a fundus camera, typically the Topcon NW400, to capture two 45° color fundus photographs per eye (one centered on the optic disc and one on the macula). These images are then uploaded to a cloud server where the IDx-DR software analyzes them for signs of diabetic retinopathy, such as hemorrhages, exudates, and neovascularizations. The analysis is completed in less than a minute.
- Results and Recommendations: The system provides clear and concise results:
- If more than mild diabetic retinopathy is detected, the system advises referring the patient to an eye care professional for further evaluation and possible treatment.
- If no more than mild diabetic retinopathy is detected, the system recommends rescreening in 12 months.
- Clinical Accuracy: IDx-DR has been evaluated in clinical studies, demonstrating high accuracy. It correctly identified the presence of more than mild diabetic retinopathy 87.4% of the time and correctly identified those without more than mild diabetic retinopathy 89.5% of the time.
- Data Security and Compliance: The system ensures compliance with data protection regulations such as GDPR, maintaining the security and confidentiality of sensitive health information, including retinal images and diagnostic reports.
Components and Functionality
- IDx-DR Analysis: This is the core software that analyzes the retinal images to determine the presence or absence of more than mild diabetic retinopathy.
- IDx-DR Client: A software application that runs on a computer connected to the fundus camera, facilitating the transfer of images to the IDx-DR Service and receiving results back.
- IDx-DR Service: This component includes a web server, database, and logging system, ensuring secure handling of incoming requests and storing user information. It is also responsible for device cybersecurity.
Indications for Use
IDx-DR is indicated for use by healthcare providers to automatically detect more than mild diabetic retinopathy in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy. It is specifically designed for use with the Topcon NW400 fundus camera.
Conclusion
In summary, IDx-DR is a revolutionary AI-based system that enhances the early detection and diagnosis of diabetic retinopathy, offering a rapid, accurate, and user-friendly solution for healthcare providers to manage diabetic eye care effectively.