Across the western healthcare landscape, artificial intelligence (AI) is being increasingly adopted to simplify authorizations and cut through layers of bureaucratic inefficiency. Rather than replacing physicians — a scenario some tech leaders like Bill Gates have speculated about — the goal is to enhance the capabilities of healthcare professionals. Momentum in this space is being driven by recent initiatives from companies like Avant Technologies, Inc., Koninklijke Philips N.V.
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The article continued: Barclays analysts forecast that the AI healthcare market will expand at a robust 30% CAGR through 2030, as investment from hospitals, insurers, and pharmaceutical giants continues to climb. A recent Deloitte study further notes that 71% of healthcare executives expect profitability to rise this year, in large part due to the growing integration of AI technologies into clinical operations.
Avant Technologies and Ainnova Request Pre-Submission Meeting with US FDA for VisionAI Platform Technology
Avant Technologies, an emerging leader in AI-driven healthcare innovation, and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced that The Center for Devices and Radiological Health of the U.S. Food and Drug Administration (FDA) has received the company’s submission package requesting a pre-submission meeting with the FDA for its VisionAI platform technology and is now under review.
Ainnova is requesting a pre-submission meeting with the FDA’s review team to discuss any questions and/or concerns about its proposed formal submission, including seeking advice to finalize the protocol and obtain agency guidance for a clinical trial of its VisionAI platform in the early detection of diabetic retinopathy. A pre-submission meeting allows companies to clarify regulatory requirements, get feedback on their plans, and potentially avoid delays or issues during the formal review process.
The clinical studies will aim to support an FDA 510(k) submission to obtain clearance from the regulatory agency to market its technology in the U.S.
Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova’s technology portfolio, including its VisionAI platform and its versatile retinal cameras, has worldwide licensing rights for this portfolio. The licensing rights include the U.S., where the FDA regulates drug and medical device development, so the success of Ainnova’s interactions with the FDA are paramount to marketing the technology portfolio in the United States.
“This milestone reflects our two-tiered strategy, rapid deployment in low-regulation markets where VisionAI operates as a screening tool, and simultaneous progress toward FDA clearance for the U.S. market,” said Vinicio Vargas, CEO at Ainnova and a member of AAC’s Board of Directors. “Entering the U.S. will unlock significant commercial potential, and early engagement with regulators ensures we do so with speed, credibility, and a validated product.”
For medical device applicants like Ainnova, the FDA’s pre-submission program is useful to determine a clear regulatory pathway for the successful launch of the device, including the number of patients and the number of clinics that will be needed to generate the necessary clinical data for the FDA to make an informed decision on Ainnova’s VisionAI platform.
For Avant, the pre-submission meeting will help define a precise budget for the strategic partnership’s entire FDA process.
This follows Ainnova’s recent strategic alignment with Apollo Hospitals in Southeast Asia, where the Vision AI platform has been cleared for commercial deployment in Brazil, and clinical pilots are being prepared across the Americas. Avant and Ainnova have identified Brazil and the United States as key strategic markets. Ainnova is currently addressing regulatory pathways in Brazil with the support of its MDSAP certification to meet ANVISA requirements, paving the way for rapid market entry.
Ainnova is being guided by global CRO Fortrea ahead of the important pre-submission meeting with the FDA. The goal is to seek 510(k) clearance for Vision AI in detecting diabetic retinopathy, a gateway to broader use across multiple chronic disease categories.
Between FDA progress, high-profile alliances, and a growing international presence, Avant Technologies continues to carve out a niche in the convergence of AI, diagnostics, and preventative care. Investors looking for small-cap exposure to the healthcare AI revolution may want to keep AVAI on the radar as these developments unfold.
