DIAGNOS Seeks FDA Approval for AI-Powered CARA System

DIAGNOS Inc. has announced its intention to file for U.S. Food and Drug Administration (FDA) pre-market authorization for its CARA SYSTEM, an AI-powered medical device designed to assist in the early detection of retinal diseases. In a press release, DIAGNOS detailed its collaboration with ORA, a clinical research organization specializing in regulatory affairs for ophthalmic products, to facilitate the FDA submission process.

The CARA SYSTEM utilizes machine learning to analyze fundus images, aiding healthcare professionals in diagnosing conditions such as diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy. This strategic move marks a significant step in DIAGNOS's expansion into the U.S. market, leveraging ORA's expertise to navigate the regulatory landscape effectively.