Avant Technologies Inc. and its joint venture partner Ainnova Tech have announced a refined patient recruitment strategy for their upcoming clinical trial of the Vision AI platform — designed for the early detection of diabetic retinopathy. Following guidance from a recent U.S. FDA meeting, Ainnova will work with Fortrea, a globally recognized Contract Research Organization (CRO) with deep expertise in ophthalmology and medical device trials.
The trial, planned across 8–10 clinical sites in the U.S., will recruit approximately 1,000 multiethnic patients, with a primary focus on individuals living with diabetes. By engaging community clinics and primary care facilities instead of specialized ophthalmology centers, the study aims to collect real-world, diverse data that mirrors everyday clinical environments. This approach is intended to ensure that Vision AI can be validated for practical use in routine diabetes care.
According to Ainnova CEO Vinicio Vargas, the collaboration with Fortrea ensures high-quality data collection, regulatory compliance, and operational efficiency. The study’s outcomes will be crucial for the company’s FDA 510(k) submission — a key step toward securing regulatory approval to market Vision AI in the U.S. market. Avant and Ainnova’s joint venture, Ai-nova Acquisition Corp. (AAC), holds global licensing rights for the technology, with U.S. entry expected to unlock major commercial potential.
If successful, the Vision AI platform could significantly improve early disease detection, enabling timely treatment to prevent vision loss in diabetic patients. The inclusion of a diverse participant base will also ensure the platform’s relevance across varied demographics, enhancing both equity and accessibility in eye care.
MedTech Summary
Avant & Ainnova to run multi-site U.S. clinical trial for Vision AI in diabetic retinopathy detection.
1,000 multiethnic patients to be recruited from community clinics and primary care settings.
Trial aims to support FDA 510(k) submission and U.S. market entry for Vision AI.
