Avant Technologies Inc. (OTCQB: AVAI), in partnership with Ainnova Tech, Inc., has confirmed that the U.S. Food and Drug Administration’s Center for Devices and Radiological Health is currently reviewing their submission package for a pre-submission meeting regarding their AI-driven VisionAI platform.
The request aims to secure a meeting with the FDA’s review team to address potential questions and receive early feedback on the formal submission strategy. Ainnova is specifically seeking agency guidance on finalizing the clinical trial protocol for using VisionAI in detecting diabetic retinopathy at an early stage. These pre-submission sessions allow companies to clarify expectations with the FDA, potentially streamlining the approval timeline.
Planned clinical trials are intended to back a future FDA 510(k) submission, which would pave the way for marketing the VisionAI platform in the U.S. pending regulatory clearance.
The initiative is being led by Ai-nova Acquisition Corp. (AAC), the joint venture entity formed by Avant and Ainnova. AAC holds the global licensing rights to Ainnova’s healthtech portfolio, including its advanced retinal imaging tools and VisionAI. The U.S. clearance remains a key objective, given FDA oversight of medical technologies.
Vinicio Vargas, CEO of Ainnova and AAC board member, emphasized, “This step marks our dual-track approach—rapid rollout in lower-regulation areas while actively pursuing U.S. entry. Early regulatory engagement boosts our credibility and accelerates commercial readiness.”
For developers like Ainnova, engaging in the FDA’s pre-submission process is essential to outline the clinical data requirements, including patient and site numbers, ensuring a well-defined path to approval. Avant also sees the meeting as a crucial step toward budgeting and planning the full FDA process tied to its collaboration with Ainnova.
About Ainnova Tech, Inc.
Based in Nevada with operations in Costa Rica and Texas, Ainnova Tech is a healthcare technology company utilizing AI to detect diseases early. Backed by industry accolades and key partnerships, Ainnova’s VisionAI platform aims to prevent vision loss and identify early diabetes onset.
About Avant Technologies Inc.
Avant Technologies Inc. is a tech-forward company focused on AI innovation across sectors. By developing advanced AI and machine learning solutions, Avant contributes to progress in industries such as healthcare.
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