Avant Technologies is set to play a critical role in supporting Ainnova Tech's upcoming U.S. Food and Drug Administration (FDA) clinical study for its Vision AI platform, focusing on early detection of diabetic retinopathy. The partnership aims to secure FDA clearance through a strategic pre-submission process that will define the clinical testing requirements.
Through their joint venture, Ai-nova Acquisition Corp. (AAC), Avant is initiating the budgeting process to support Ainnova's FDA interactions. The companies plan to request a pre-submission meeting in late March or early April 2025 to establish a clear regulatory pathway for their innovative healthcare technology.
The FDA's pre-submission program will help determine the necessary clinical data requirements, including the number of patients and clinics needed to validate the Vision AI platform. This process is crucial for Ainnova, as it seeks to obtain a 510(k) clearance to market its technology in the United States.
Beyond diabetic retinopathy, Ainnova is also seeking FDA guidance on four additional algorithms targeting early detection of cardiovascular risk, prediabetes, Type 2 diabetes, fatty liver disease, and chronic kidney disease. This comprehensive approach underscores the potential of AI in transforming preventative healthcare.
The collaboration represents a significant step in leveraging artificial intelligence for early disease detection, with the potential to improve patient outcomes and reduce healthcare costs through proactive diagnostic technologies.
