Diagnos Inc to submit FDA pre-market authorization for CARA SYSTEM
This device is designed to assist healthcare professionals in analyzing fundus images for the early detection of key retinal conditions.
(Image credit: AdobeStock/NASSRI)
Diagnos Inc. will file for US Food and Drug Administration (FDA) pre-market authorization of its CARA SYSTEM. This is a machine-learning-enabled medical device (MLMD) that is designed to assist optometrists and frontline healthcare professionals in analyzing fundus images for the early detection of diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy.1
To ensure a smooth regulatory process, DIAGNOS has engaged ORA, a leading clinical research organization specializing in regulatory affairs and clinical development for ophthalmic products. ORA will play a pivotal role in navigating the US regulatory landscape and ensuring a successful FDA submission process.1
André Larente, CEO of Diagnos, shared his thoughts on this milestone in the company’s growth in the news release1, saying, “Diagnos is committed to revolutionizing eye health through Artificial Intelligence technologies. Our expertise in Artificial Intelligence driven diagnostics is helping to improve patient outcomes worldwide. The optometry market comprises over 300,000 sites globally, and our recent partnership with the largest player in the industry will significantly boost our visibility. Additionally, our government-related business initiatives are resuming, marking an exciting phase of growth for Diagnos.”
Diagnos Inc. is headquartered in Brossard, Canada.
