Avant Technologies and Ainnova Design Clinical Trial for AI Vision Platform

Avant Technologies Inc. and Ainnova Tech, Inc. are collaborating on the development of a clinical trial protocol for their Vision AI platform. This move is in preparation for a pre-submission meeting with the U.S. Food and Drug Administration (FDA) scheduled for mid-May 2025. The meeting aims to secure guidance on clinical tests necessary for the platform's early detection of diabetic retinopathy.

An ophthalmologist is assisting Ainnova in drafting clinical trial requirements. Fortrea, the Contract Research Organization (CRO), will submit the necessary documentation to the FDA. The outcome of this process is crucial for Ai-nova Acquisition Corp., which holds global licensing rights to Ainnova's portfolio.

The pre-submission program helps applicants like Ainnova outline a regulatory pathway for device launch. It also assists Avant in budgeting for the FDA process. Success with the FDA would allow marketing of Ainnova's technology portfolio in the U.S.