Business
Avant Technologies and JV Partner, Ainnova, Complete Pivotal Meeting with U.S. FDA
Avant Technologies Inc. (OTCQB: AVAI) ("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 the completion of its milestone meeting with the U.S. Food and Drug Administration (FDA). The pre-submission meeting allowed Ainnova and its Contract Research Organization (CRO), Fortrea, to present and discuss Ainnova's planned clinical tr
About this update from Fortrea Holdings Inc.
[{"type":"text","content":"LAS VEGAS, July 15, 2025 /CNW/ -- Avant Technologies Inc. (OTCQB: AVAI) ("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 the completion of its milestone meeting with the U.S. Food and Drug Administration (FDA). The pre-submission meeting allowed Ainnova and its Contract Research Organization (CRO), Fortrea, to present and discuss Ainnova's planned clinical trial for its Vision AI platform in the early detection of diabetic retinopathy and receive critical feedback from the FDA.","length":679,"tagName":"p"},{"type":"image","alt":"Avant Technologies Logo (PRNewsfoto/Avant Technologies Inc.)","displaySize":"","headline":null,"caption":"Avant Technologies Logo (PRNewsfoto/Avant Technologies Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":121,"url":"https://media.zenfs.com/en/cnwgroup.com/3c138b168ab03629793c000c528b718b"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/f4V8JEZWrElhBKP1gsBg8w--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTIxMztjZj13ZWJw/https://media.zenfs.com/en/cnwgroup.com/3c138b168ab03629793c000c528b718b","width":400,"height":121}},"href":"https://mma.prnewswire.com/media/2370694/Avant_Technologies.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":"Ainnova's clinical trial will be conducted exclusively in the United States and focus solely on diabetic retinopathy. The FDA has now provided the Company with valuable guidance on its clinical protocol, the number and type of clinics Ainnova will need to conduct a successful clinical trial, the number of retinologists required to examine the images generated by Ainnova's Vision AI, etc.","length":398,"tagName":"p"},{"type":"text","content":"With the FDA's recommendations, the Company can now actively plan for the total cost of conducting this planned clinical trial through to completion. Data from Ainnova's trial will support the Company's FDA 510(k) submission to obtain clearance from the FDA to market the Vision AI technology in the United States.","length":326,"tagName":"p"},{"type":"text","content":"Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nov...