Avant Technologies and Ainnova Seek FDA Meeting for VisionAI

Avant Technologies, Inc. and Ainnova Tech, Inc. have jointly requested a pre-submission meeting with the FDA to discuss their VisionAI platform technology. The FDA's Center for Devices and Radiological Health is currently reviewing the submission. This meeting aims to address questions regarding the planned formal submission and to obtain guidance for a clinical trial targeting early detection of diabetic retinopathy.

The goal is to support the FDA 510(k) submission, required for U.S. marketing clearance. Ai-nova Acquisition Corp., formed by Avant and Ainnova, holds exclusive rights to the VisionAI platform. Vinicio Vargas, CEO of Ainnova, emphasized the strategic importance of the FDA clearance to harness commercial potential in the U.S. market.

The pre-submission is crucial for defining regulatory pathways and setting a clear budget for the entire FDA process. The U.S. market entry is part of a broader strategy to position VisionAI as a leading tool for disease screening and early detection.