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DIAGNOS to File for FDA Pre-Market Authorization of Its AI-Powered CARA SYSTEM and Engages Ora as Regulatory Specialist

Feb 25, 2025 - financialpost.com
Diagnos Inc., a Canadian corporation specializing in AI-driven diagnostics, is filing for FDA pre-market authorization for its CARA SYSTEM, a machine-learning-enabled medical device designed to assist in the early detection of diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy. To facilitate the U.S. regulatory process, Diagnos has partnered with ORA, a leading clinical research organization with extensive experience in ophthalmic product approvals. This strategic collaboration marks a significant step in Diagnos' expansion strategy, aiming to enhance diagnostic accuracy and improve patient outcomes globally.

The CARA SYSTEM leverages AI to analyze fundus images, streamlining workflows for optometrists and healthcare professionals. Diagnos CEO André Larente emphasized the company's commitment to revolutionizing eye health through AI technologies, highlighting the potential impact on the global optometry market. ORA, with over 45 years of experience and more than 85 product approvals, will play a crucial role in guiding the FDA submission process. Diagnos continues to focus on growth and visibility in the industry, supported by its government-related business initiatives.

Key takeaways:

  • DIAGNOS is filing for FDA pre-market authorization for its AI-powered CARA SYSTEM, designed for early detection of eye diseases.
  • DIAGNOS has partnered with ORA, a leading clinical research organization, to navigate the U.S. regulatory process.
  • The CARA SYSTEM aims to assist healthcare professionals in diagnosing diabetic retinopathy, age-related macular degeneration, and hypertensive retinopathy.
  • DIAGNOS is focused on expanding its market presence and improving patient outcomes through AI-driven diagnostics.
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