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This foresight equips healthcare providers with valuable information to strategize long-term management plans, optimizing outcomes for patients with diabetic retinopathy.” Avant Technologies, Inc.(OTCQB: AVAI) and Ainnova Request Pre-Submission Meeting with US FDA for VisionAI Platform Technology - Avant Technologies, Inc.("Avant” or the "Company”), 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.
Vinicio Vargas, Chief Executive Officer at Ainnova and a member of AAC’s Board of Directors, said, "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.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.
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