Latest news with #AinnovaTech
Globe and Mail
7 days ago
- Business
- Globe and Mail
Regulatory Green Lights Are Powering the Next Phase of the AI Health Boom
Issued on behalf of Avant Technologies Inc. VANCOUVER – News Commentary – Artificial intelligence is rapidly transforming the healthcare landscape, unlocking new possibilities for early detection, patient care, and operational efficiency. Startups across the sector are deploying AI-driven tools to expand patient access, streamline workflows, and generate scalable revenue models that appeal to forward-looking investors. With usage accelerating among both patients and providers, AI-powered diagnostics and treatment platforms are quickly becoming standard practice. As regulatory hurdles begin to fall, several innovators are approaching key commercial inflection points—including Avant Technologies, Inc. (OTCQB: AVAI), AI Inc. (CSE: TRUE) (OTCQB: TREIF), Schrödinger, Inc. (NASDAQ: SDGR), Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX), and Rallybio Corporation (NASDAQ: RLYB). The AI healthcare market is expected to top US$110 billion by 2030, but Accenture suggests the upside could be far greater—projecting over US$461 billion in additional value creation by 2035, layered on top of a sector already forecasted to exceed US$2.26 trillion. Avant Technologies, Inc. (OTCQB: AVAI) and joint-venture partner Ainnova Tech are continuing to raise visibility for their AI-powered diagnostic platform, with Ainnova CEO Vinicio Vargas recently featured as a speaker at Roche's 'Macular Spectacular' Ophthalmology Conference in Cartagena, Colombia. The event brought together leading voices in visual health from across Latin America, with discussions focused on advancing patient outcomes through AI innovation. Vargas, who also sits on the board of Ai-nova Acquisition Corp. (AAC), presented Vision AI as a transformative tool to expand access to early diabetic retinopathy screening and reduce preventable blindness throughout the region. Vargas also highlighted a Q4 2024 alliance with Roche and prepaid‑health‑plan provider Salud 360 that is piloting Vision AI among high‑risk diabetic patients; if successful, the program will be rolled out in the United States, Canada, and Europe through Ai ‑ nova Acquisition Corp. (AAC), which holds worldwide rights to Ainnova's technology portfolio . This momentum builds on a recent regulatory breakthrough in the U.S. market. Avant and Ainnova recently completed a key pre-submission meeting with the FDA for Vision AI, the companies' flagship diagnostic platform for diabetic retinopathy and other retinal diseases. 'We're truly excited about this next phase,' said Vinicio Vargas, CEO at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio. 'We're getting ready to begin data collection across primary care clinics in the U.S. with a study that is simple, yet rigorous—comparing our AI-based retinal screening to the readings of three retinologists. The July 15 meeting marked a critical step toward securing 510(k) clearance for Vision AI. The FDA session offered clear feedback on study design, site selection, and execution strategy—enabling Ainnova and its clinical trial partner, Fortrea, to finalize preparations for U.S.-based trials. 'This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera,' added Vargas. 'We believe will [it] be a game changer—making diabetic retinal screenings faster, more accessible, and available from virtually any point of care.' While regulatory efforts advance in the U.S., the company has already launched a groundbreaking chronic care model across Latin America. The program, now live through Grupo Dökka's Fischel and La Bomba pharmacy chains, offers free, walk-in retinal risk assessments—delivering real-time AI results and connecting at-risk patients directly with clinics and specialists. Over 30% of diabetics develop diabetic retinopathy, a leading cause of preventable blindness. Vision AI offers early, low-cost screening without the need for an ophthalmologist onsite. The model has gained support from pharmacies, insurers, and pharmaceutical partners—demonstrating real traction across the healthcare value chain. Avant' s role in these efforts continues to grow. Through Ai-nova Acquisition Corp., which it co-founded and structured, Avant maintains global licensing rights to Ainnova's platform and stands to benefit from both U.S. and international commercialization. The Latin American pilot programs are already generating momentum, with U.S. trials positioned to unlock a vastly larger market. The company is also preparing a standalone venture to house a potential therapeutic candidate for diabetes—bringing leadership, data, and IP into one streamlined structure for diagnostics and treatment alike. Looking ahead, Vision AI could serve as a frontline tool for broader disease detection. Ainnova's future roadmap includes a cloud-connected retinal camera for rural clinics and new modules aimed at identifying Alzheimer's, cardiovascular conditions, and other chronic diseases through retinal or blood biomarkers. A structural simplification may be on the horizon as well. A previously announced non-binding LOI remains active for Avant to acquire 100% of Ainnova Tech —potentially consolidating all IP, leadership, and commercial rights under one public entity. Such a move would give investors pure-play exposure to this fast-evolving tech stack, while deepening operational alignment between the firms. AI Inc. (CSE: TRUE) (OTCQB: TREIF) and its digital health platform Rocket Doctor have diverted thousands of low-acuity patients from overwhelmed Canadian emergency rooms using smart triage, AI tools, and virtual MD visits. 'We see so many patients in our rural, remote and even urban communities going to ED, often when they recognize that they could be seen outside the hospital.' Said Dr. William Cherniak, CEO of Rocket Doctor. 'There has been a lot of good content from the Canadian Association of Emergency Physicians (CAEP) to recognize that we need to support patients to access healthcare where they see most appropriate. We often see patients choose an ED with low-acuity issues simply because of a lack of access to family doctors, or other accessible out-patient choices.' Their program at Georgian Bay General Hospital alone saved an estimated CA$1.4 million and resolved 97.5% of patient cases virtually. With over 12,000 recent visits in Alberta and continued provincial expansion, the AI-powered system is proving its value at scale Schrödinger, Inc. (NASDAQ: SDGR) received FDA Fast Track designation for its AI-discovered MALT1 inhibitor, SGR-1505, targeting relapsed/refractory Waldenström macroglobulinemia. "We are excited to receive Fast Track designation for SGR-1505, which underscores the significant need in patients with Waldenström macroglobulinemia," said Karen Akinsanya, Ph.D., president, head of therapeutics R&D and chief strategy officer, partnerships at Schrödinger. "Despite the continued therapeutic advances in the treatment of hematologic malignancies, treatment failure and disease progression due to BTK resistance remains a challenge for a growing number of patients. This unmet need represents an opportunity for novel mechanisms such as MALT1 as monotherapy and as part of new combination regimens." The drug candidate, developed using Schrödinger's proprietary computational platform, has shown promising early results across several B-cell malignancies. This milestone highlights the growing role of AI-driven molecular discovery in accelerating cancer drug development. Recursion Pharmaceuticals, Inc. (NASDAQ: RXRX) has acquired full rights to REV102, a potential first-in-class oral therapy for hypophosphatasia (HPP), a rare genetic bone disorder with limited treatment options. Developed in collaboration with Rallybio Corporation (NASDAQ: RLYB), REV102 targets the ENPP1 enzyme and is being positioned as a convenient, non-immunogenic alternative to costly injectable enzyme replacement therapies. 'We extend our sincere thanks to Rallybio for their invaluable partnership in advancing this program to its current stage,' said David Hallett, Chief Scientific Officer of Recursion. 'Having full ownership of this important program allows Recursion to accelerate the development of the first potential oral disease-modifying treatment to HPP patients, who currently face significant challenges with limited access to existing therapies. While this is a preclinical asset that will require further study, we look forward to leveraging the full power of the Recursion OS to gain even deeper insights and accelerate delivery of the potential treatment.' Recursion used its proprietary AI-driven Recursion OS to design and optimize the drug, which has shown promising preclinical results and is expected to enter Phase 1 trials in 2026. 'The Rallybio team has long been committed to targeting ENPP1 to address a significant unmet need in patients with HPP,' said Stephen Uden, M.D., CEO of Rallybio. 'By combining Rallybio's expertise in HPP preclinical and translational research with Recursion's integrated AI/experimental platform, we transformed this concept into the first potential oral disease-modifying treatment for HPP. We look forward to the advancement of REV102 through key milestones and, ultimately, to the delivery of this important treatment to patients in need.' Under the deal, Rallybio will receive equity, milestones, and royalties as Recursion advances development. CONTACT: cs@ (250) 999-4849 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. is a wholly-owned subsidiary of Media Corp. ('BAY') BAY has been not been paid a fee for Avant Technologies Inc. advertising and/or digital media, but the owner(s) of BAY also own Market IQ Media Group, Inc., which has been paid a fee from the company directly. There may be 3rd parties who may have shares Avant Technologies Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of BAY own shares of Avant Technologies Inc. which were purchased in the open market. BAY and all of it's respective employees, owners and affiliates reserve the right to buy and sell, and will buy and sell shares of Avant Technologies Inc. at any time thereafter without any further notice. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material disseminated by BAY has been approved by the above mentioned company; this is a paid advertisement, and we own shares of the mentioned company that we will sell, and we also reserve the right to buy shares of the company in the open market, or through other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. 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Globe and Mail
7 days ago
- Business
- Globe and Mail
Avant Technologies' Joint Venture Partner Presents AI Technology at Roche Ophthalmology Conference
LAS VEGAS , July 22, 2025 /CNW/ -- Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions using both artificial intelligence (AI) and developments in biotechnology, today announced that Vinicio Vargas , Chief Executive Officer (CEO) of Avant's partner, Ainnova Tech, Inc., (Ainnova), was a featured speaker Friday and Saturday at Roche's Latin America "Macular Spectacular" Ophthalmology conference in Cartagena, Colombia . The conference highlighted the latest in scientific advances in treatments for the most common eye diseases, including age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, while also focusing on strengthening collaboration between industry specialists in Latin America . Ainnova's CEO, Vinicio Vargas , who is also a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, discussed the status of AI and its uses in the industry to improve patient outcomes. Vargas and a host of renowned speakers that included Dr. Laura Velásquez, Dr. Roberto Gallego , Hugo Ocampo , and other ophthalmologists and experts presented the latest tools to transform visual health in the region, reflected on unmet needs, and explained how innovation can help build stronger, accessible, and patient-centered health systems. In Q4 2024, Ainnova entered a strategic alliance with global biotech, Roche, and leading prepaid health plan provider, Salud 360, to start a pilot program to combat diabetic retinopathy using Ainnova's AI-powered, cutting-edge technology, Vision AI. The alliance aims at improving access to vision screening in patients with uncontrolled diabetes with the hope of decreasing the risks of diabetic retinopathy. If the program is successful, Avant and Ainnova hope to implement a similar program in the United States , Canada , and Europe through AAC. AAC has the worldwide licensing rights for Ainnova's technology portfolio, which includes Ainnova's Vision AI platform. About Ainnova Tech, Inc. Ainnova is a Nevada -based healthtech startup with headquarters in San Jose, Costa Rica , and Houston, Texas . Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce Vision AI – our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions. About Avant Technologies Inc. Avant Technologies Inc. is an emerging technology company developing solutions in healthcare using artificial intelligence and biotechnologies. With a focus on pushing the boundaries of what is possible in AI and biotechnology, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology. More information about Avant can be found at You can also follow us on social media at: Forward-Looking Statements Certain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release.
Yahoo
7 days ago
- Business
- Yahoo
Avant Technologies' Joint Venture Partner Presents AI Technology at Roche Ophthalmology Conference
LAS VEGAS, July 22, 2025 /PRNewswire/ -- Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions using both artificial intelligence (AI) and developments in biotechnology, today announced that Vinicio Vargas, Chief Executive Officer (CEO) of Avant's partner, Ainnova Tech, Inc., (Ainnova), was a featured speaker Friday and Saturday at Roche's Latin America "Macular Spectacular" Ophthalmology conference in Cartagena, Colombia. The conference highlighted the latest in scientific advances in treatments for the most common eye diseases, including age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, while also focusing on strengthening collaboration between industry specialists in Latin America. Ainnova's CEO, Vinicio Vargas, who is also a member of the Board of Directors of Ai-nova Acquisition Corp. (AAC), the company formed by the partnership between Avant and Ainnova to advance and commercialize Ainnova's technology portfolio, discussed the status of AI and its uses in the industry to improve patient outcomes. Vargas and a host of renowned speakers that included Dr. Laura Velásquez, Dr. Roberto Gallego, Hugo Ocampo, and other ophthalmologists and experts presented the latest tools to transform visual health in the region, reflected on unmet needs, and explained how innovation can help build stronger, accessible, and patient-centered health systems. In Q4 2024, Ainnova entered a strategic alliance with global biotech, Roche, and leading prepaid health plan provider, Salud 360, to start a pilot program to combat diabetic retinopathy using Ainnova's AI-powered, cutting-edge technology, Vision AI. The alliance aims at improving access to vision screening in patients with uncontrolled diabetes with the hope of decreasing the risks of diabetic retinopathy. If the program is successful, Avant and Ainnova hope to implement a similar program in the United States, Canada, and Europe through AAC. AAC has the worldwide licensing rights for Ainnova's technology portfolio, which includes Ainnova's Vision AI platform. About Ainnova Tech, Inc. Ainnova is a Nevada-based healthtech startup with headquarters in San Jose, Costa Rica, and Houston, Texas. Founded by an experienced and innovative team that is dedicated to leveraging artificial intelligence for early disease detection. Recognized with multiple global awards and renowned partnerships with hospitals and medical device companies, we proudly introduce Vision AI – our cutting-edge platform designed to prevent blindness and detect the early onset of diabetes. Explore how Ainnova is revolutionizing healthcare through advanced technology and proactive solutions. About Avant Technologies Inc. Avant Technologies Inc. is an emerging technology company developing solutions in healthcare using artificial intelligence and biotechnologies. With a focus on pushing the boundaries of what is possible in AI and biotechnology, Avant serves a diverse range of industries, driving progress and efficiency through state-of-the-art technology. More information about Avant can be found at You can also follow us on social media at: Forward-Looking Statements Certain statements contained in this press release may constitute "forward-looking statements." Forward-looking statements provide current expectations of future events based on certain assumptions and include any statement that does not directly relate to any historical or current fact. Actual results may differ materially from those indicated by such forward-looking statements because of various important factors as disclosed in our filings with the Securities and Exchange Commission located at their website ( In addition to these factors, actual future performance, outcomes, and results may differ materially because of more general factors including (without limitation) general industry and market conditions and growth rates, economic conditions, governmental and public policy changes, the Company's ability to raise capital on acceptable terms, if at all, the Company's successful development of its products and the integration into its existing products and the commercial acceptance of the Company's products. The forward-looking statements included in this press release represent the Company's views as of the date of this press release and these views could change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date after the date of the press release. Contact: Avant Technologies Logo - View original content to download multimedia: SOURCE Avant Technologies Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
17-07-2025
- Business
- Associated Press
Ainnova Tech Reaches Major FDA Milestone in AI-Powered Diabetic Retinopathy Detection
Revolutionary Vision AI platform moves closer to US market approval following successful FDA pre-submission meeting The healthcare technology landscape took a significant step forward this week as Ainnova Tech, Inc., in partnership with Avant Technologies Inc. (OTCQB: AVAI) announced the successful completion of a crucial milestone meeting with the U.S. Food and Drug Administration (FDA). This pivotal moment brings the company's groundbreaking Vision AI platform one step closer to revolutionizing early diabetic retinopathy detection in the United States. FDA Guidance Paves the Way Forward The pre-submission meeting represented a critical juncture for Ainnova and its Contract Research Organization (CRO), Fortrea. During this session, the team presented their comprehensive clinical trial plans for the Vision AI platform, focusing exclusively on diabetic retinopathy detection within the United States market. The FDA's response has been overwhelmingly constructive, providing essential guidance across multiple aspects of the clinical trial process. The regulatory body offered specific recommendations regarding clinical protocol development, the optimal number and types of clinics required for a successful trial, and the necessary number of retinologists needed to examine images generated by the AI platform. This detailed feedback enables Ainnova to accurately plan and budget for the complete clinical trial process, creating a clear pathway to their ultimate goal: FDA 510(k) submission and clearance to market Vision AI technology in the United States. A Game-Changing Approach to Diabetic Eye Care Vinicio Vargas, Chief Executive Officer at Ainnova and Board member of Ai-nova Acquisition Corp. (AAC), expressed enthusiasm about this next phase of development. 'We're truly excited about this next phase. We're getting ready to begin data collection across primary care clinics in the U.S. with a study that is simple, yet rigorous - comparing our AI-based retinal screening to the readings of three retinologists.' The clinical trial design reflects Ainnova's commitment to both simplicity and scientific rigor. By comparing AI-generated results directly with expert retinologist evaluations, the study will provide compelling evidence of the technology's effectiveness and reliability. Beyond Current Technology: The Automated Retinal Camera The Vision AI platform represents just one component of Ainnova's comprehensive technology portfolio. Vargas highlighted the upcoming approval of their automated retinal camera, which he believes will be truly transformative for the industry. 'This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera, which we believe will be a game changer - making diabetic retinal screenings faster, more accessible, and available from virtually any point of care.' This automated camera technology promises to democratize diabetic retinopathy screening by making it available across diverse healthcare settings, potentially reaching patients who might otherwise lack access to specialized retinal examinations. Strategic Partnership Unlocks Global Potential The partnership between Avant Technologies Inc. and Ainnova Tech has created AAC (Ai-nova Acquisition Corp.), which holds worldwide licensing rights for Ainnova's entire technology portfolio. This strategic arrangement is particularly significant given the FDA's regulatory authority over drug and medical device development in the United States. Success in the U.S. clinical trial will unlock substantial commercial potential, with the early FDA engagement ensuring that AAC can enter the market with speed, credibility, and a thoroughly validated product. The U.S. healthcare market represents the world's largest opportunity for medical technology companies, making FDA approval a crucial milestone for global expansion. Innovation Rooted in Experience Ainnova Tech brings impressive credentials to this endeavor. Based in Nevada with headquarters spanning San Jose, Costa Rica, and Houston, Texas, the company was founded by an experienced team dedicated to leveraging artificial intelligence for early disease detection. The company's track record includes multiple global awards and established partnerships with hospitals and medical device companies worldwide. This recognition underscores the quality and potential impact of their technological innovations. The Broader Vision: Preventing Blindness, Detecting Disease The Vision AI platform represents more than just a diagnostic tool—it embodies a proactive approach to healthcare that prioritizes prevention over treatment. By enabling early detection of diabetic retinopathy, the technology has the potential to prevent blindness while simultaneously facilitating early diabetes detection. This dual benefit aligns with broader healthcare trends toward preventive medicine and early intervention, potentially reducing long-term healthcare costs while improving patient outcomes. Technology Partnership Driving Innovation Avant Technologies Inc., Ainnova's partner in this venture, brings complementary expertise in artificial intelligence and biotechnology solutions. As an emerging technology company focused on pushing the boundaries of what's possible in AI and biotechnology, Avant serves diverse industries while driving progress and efficiency through state-of-the-art technology. This partnership combines Ainnova's specialized healthcare focus with Avant's broader technological capabilities, creating a powerful platform for innovation and commercialization. Looking Ahead: The Path to Market With FDA guidance now in hand, Ainnova can begin the detailed planning phase for their clinical trial. The company will work to establish partnerships with primary care clinics across the United States, recruit the necessary retinologists for image evaluation, and implement the clinical protocol refined through FDA feedback. The data generated from this trial will form the foundation of their FDA 510(k) submission, representing the final regulatory hurdle before market entry. Success in this process would establish Ainnova as a leader in AI-powered diabetic retinopathy detection and position the company for significant growth in the expanding digital health market. Conclusion: A New Era in Diabetic Care The successful completion of Ainnova's FDA milestone meeting represents more than a regulatory achievement—it signals the beginning of a new era in diabetic eye care. By combining artificial intelligence with rigorous clinical validation, Ainnova is positioned to make diabetic retinopathy screening more accessible, efficient, and effective than ever before. As the company moves forward with their clinical trial, the healthcare industry will be watching closely. The potential to prevent blindness while enabling early diabetes detection represents a significant advancement in preventive medicine, with implications that extend far beyond individual patient care to broader public health outcomes. The partnership between Ainnova Tech and Avant Technologies, formalized through AAC, demonstrates how strategic collaboration can accelerate medical innovation and bring life-changing technologies to market. With FDA guidance secured and clinical trials on the horizon, Ainnova is well-positioned to transform the landscape of diabetic retinopathy detection and prevention. Other Active healthcare/tech companies active in the diabetes treatment industry include Abbott (NYSE: ABT), DexCom, Inc. (NASDAQ: DXCM), iRhythm Technologies, Inc. (NASDAQ: IRTC), Tandem Diabetes Care, Inc. (NASDAQ: TNDM). Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of COEP or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at Source: Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: [email protected] City: Frisco State: Texas Country: United States Website: Press Release Distributed by To view the original version on ABNewswire visit: Ainnova Tech Reaches Major FDA Milestone in AI-Powered Diabetic Retinopathy Detection
Globe and Mail
17-07-2025
- Business
- Globe and Mail
Ainnova Tech Reaches Major FDA Milestone in AI-Powered Diabetic Retinopathy Detection
Revolutionary Vision AI platform moves closer to US market approval following successful FDA pre-submission meeting The healthcare technology landscape took a significant step forward this week as Ainnova Tech, Inc., in partnership with Avant Technologies Inc. (OTCQB: AVAI) announced the successful completion of a crucial milestone meeting with the U.S. Food and Drug Administration (FDA). This pivotal moment brings the company's groundbreaking Vision AI platform one step closer to revolutionizing early diabetic retinopathy detection in the United States. FDA Guidance Paves the Way Forward The pre-submission meeting represented a critical juncture for Ainnova and its Contract Research Organization (CRO), Fortrea. During this session, the team presented their comprehensive clinical trial plans for the Vision AI platform, focusing exclusively on diabetic retinopathy detection within the United States market. The FDA's response has been overwhelmingly constructive, providing essential guidance across multiple aspects of the clinical trial process. The regulatory body offered specific recommendations regarding clinical protocol development, the optimal number and types of clinics required for a successful trial, and the necessary number of retinologists needed to examine images generated by the AI platform. This detailed feedback enables Ainnova to accurately plan and budget for the complete clinical trial process, creating a clear pathway to their ultimate goal: FDA 510(k) submission and clearance to market Vision AI technology in the United States. A Game-Changing Approach to Diabetic Eye Care Vinicio Vargas, Chief Executive Officer at Ainnova and Board member of Ai-nova Acquisition Corp. (AAC), expressed enthusiasm about this next phase of development. "We're truly excited about this next phase. We're getting ready to begin data collection across primary care clinics in the U.S. with a study that is simple, yet rigorous - comparing our AI-based retinal screening to the readings of three retinologists." The clinical trial design reflects Ainnova's commitment to both simplicity and scientific rigor. By comparing AI-generated results directly with expert retinologist evaluations, the study will provide compelling evidence of the technology's effectiveness and reliability. Beyond Current Technology: The Automated Retinal Camera The Vision AI platform represents just one component of Ainnova's comprehensive technology portfolio. Vargas highlighted the upcoming approval of their automated retinal camera, which he believes will be truly transformative for the industry. "This milestone not only brings us closer to validating our platform in the world's largest healthcare market, but it also paves the way for the upcoming approval of our new automated retinal camera, which we believe will be a game changer - making diabetic retinal screenings faster, more accessible, and available from virtually any point of care." This automated camera technology promises to democratize diabetic retinopathy screening by making it available across diverse healthcare settings, potentially reaching patients who might otherwise lack access to specialized retinal examinations. Strategic Partnership Unlocks Global Potential The partnership between Avant Technologies Inc. and Ainnova Tech has created AAC (Ai-nova Acquisition Corp.), which holds worldwide licensing rights for Ainnova's entire technology portfolio. This strategic arrangement is particularly significant given the FDA's regulatory authority over drug and medical device development in the United States. Success in the U.S. clinical trial will unlock substantial commercial potential, with the early FDA engagement ensuring that AAC can enter the market with speed, credibility, and a thoroughly validated product. The U.S. healthcare market represents the world's largest opportunity for medical technology companies, making FDA approval a crucial milestone for global expansion. Innovation Rooted in Experience Ainnova Tech brings impressive credentials to this endeavor. Based in Nevada with headquarters spanning San Jose, Costa Rica, and Houston, Texas, the company was founded by an experienced team dedicated to leveraging artificial intelligence for early disease detection. The company's track record includes multiple global awards and established partnerships with hospitals and medical device companies worldwide. This recognition underscores the quality and potential impact of their technological innovations. The Broader Vision: Preventing Blindness, Detecting Disease The Vision AI platform represents more than just a diagnostic tool—it embodies a proactive approach to healthcare that prioritizes prevention over treatment. By enabling early detection of diabetic retinopathy, the technology has the potential to prevent blindness while simultaneously facilitating early diabetes detection. This dual benefit aligns with broader healthcare trends toward preventive medicine and early intervention, potentially reducing long-term healthcare costs while improving patient outcomes. Technology Partnership Driving Innovation Avant Technologies Inc., Ainnova's partner in this venture, brings complementary expertise in artificial intelligence and biotechnology solutions. As an emerging technology company focused on pushing the boundaries of what's possible in AI and biotechnology, Avant serves diverse industries while driving progress and efficiency through state-of-the-art technology. This partnership combines Ainnova's specialized healthcare focus with Avant's broader technological capabilities, creating a powerful platform for innovation and commercialization. Looking Ahead: The Path to Market With FDA guidance now in hand, Ainnova can begin the detailed planning phase for their clinical trial. The company will work to establish partnerships with primary care clinics across the United States, recruit the necessary retinologists for image evaluation, and implement the clinical protocol refined through FDA feedback. The data generated from this trial will form the foundation of their FDA 510(k) submission, representing the final regulatory hurdle before market entry. Success in this process would establish Ainnova as a leader in AI-powered diabetic retinopathy detection and position the company for significant growth in the expanding digital health market. Conclusion: A New Era in Diabetic Care The successful completion of Ainnova's FDA milestone meeting represents more than a regulatory achievement—it signals the beginning of a new era in diabetic eye care. By combining artificial intelligence with rigorous clinical validation, Ainnova is positioned to make diabetic retinopathy screening more accessible, efficient, and effective than ever before. As the company moves forward with their clinical trial, the healthcare industry will be watching closely. The potential to prevent blindness while enabling early diabetes detection represents a significant advancement in preventive medicine, with implications that extend far beyond individual patient care to broader public health outcomes. The partnership between Ainnova Tech and Avant Technologies, formalized through AAC, demonstrates how strategic collaboration can accelerate medical innovation and bring life-changing technologies to market. With FDA guidance secured and clinical trials on the horizon, Ainnova is well-positioned to transform the landscape of diabetic retinopathy detection and prevention. Other Active healthcare/tech companies active in the diabetes treatment industry include Abbott (NYSE: ABT), DexCom, Inc. (NASDAQ: DXCM), iRhythm Technologies, Inc. (NASDAQ: IRTC), Tandem Diabetes Care, Inc. (NASDAQ: TNDM). Disclaimer: This blog post is for informational purposes only and does not constitute financial advice or an endorsement of COEP or its strategies. FOR EDUCATIONAL AND INFORMATION PURPOSES ONLY; NOT INVESTMENT ADVICE. Please ensure to fully read and comprehend our disclaimer found at has been compensated one thousand dollars by a 3rd party EDM Media for content distribution services on AVAI for July 17, 2025. is neither an investment advisor nor a registered broker. 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Source: Media Contact Company Name: UsaStockReport Contact Person: Ash K Email: editor@ City: Frisco State: Texas Country: United States Website:
