Retina-Ai Health, Inc.

Retina-Ai Health, Inc. specializes in ophthalmic fundus cameras, such as the CADENCE model. These devices are designed to capture high-resolution retinal images, which are essential for diagnosing and monitoring eye conditions like diabetic retinopathy, glaucoma, and age-related macular degeneration.

Retina-Ai Health, Inc. is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those governed by the FDA.

Retina-Ai Health, Inc.’s ophthalmic fundus cameras, including the CADENCE model, are classified as Class II devices by the FDA. This classification applies to devices that generally pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, Retina-Ai Health, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and patient safety purposes.