Latest news with #Ainnova
Cision Canada
2 days ago
- Business
- Cision Canada
AI Just Got a Green Light from the White House--Here's What That Means for Healthcare Stocks
VANCOUVER, BC, July 29, 2025 /CNW/ -- Equity Insider News Commentary – There's a lot of big voices pushing for the AI revolution to make its mark, including a new plan from the U.S. Department of Commerce to address slow-to-adopt sectors like healthcare. The comes as part of US President Trump's paper, titled Winning the Race: AMERICA'S AI ACTION PLAN, which encourages setting up regulatory sandboxes, or regulation-free environments where AI can be tested in real world scenarios with heavy oversight. As the market evaluates the opportunities available, several tech and biotech companies are already moving towards major milestones in AI-powered healthcare solutions, including Avant Technologies, Inc. (OTCQB: AVAI), Renovaro Inc. (NASDAQ: RENB), Healthcare Triangle, Inc. (NASDAQ: HCTI), GE HealthCare Technologies Inc. (NASDAQ: GEHC), and Spectral AI, Inc. (NASDAQ: MDAI). According to Accenture, AI could inject an additional $461 billion into the healthcare sector by 2035, as it surpasses the $2.26 trillion mark. Now, as AI makes its move into the healthcare space, experts are working to help guide these new solutions towards being more accurate, in a space where AI's inaccuracies (known as "hallucinations") are not an option. Thankfully, there are several players making important advancements in diagnostics, drug development, and workflow, through the use of AI. Avant Technologies, Inc. (OTCQB: AVAI) and joint-venture partner Ainnova Tech have taken a key regulatory step forward by finalizing an updated clinical trial protocol for their AI-powered Vision AI platform, following formal feedback from a mid-July pre-submission meeting with the FDA. The revised protocol, which addresses the FDA's comments, has now been presented to Fortrea, the company's contract research organization, for review. Once approved, the protocol will enable the launch of a new U.S.-based clinical trial designed to support Ainnova's goal of obtaining FDA 510(k) clearance for Vision AI in the early detection of diabetic retinopathy. "We are committed to meeting the highest regulatory standards, and we're confident that these protocol refinements will strengthen our path toward FDA 510(k) clearance," 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 anticipate finalizing the clinical trial budget soon, with estimated costs coming more into focus as we refine our protocol and navigate the process." The U.S. regulatory push builds on expanding visibility for Vision AI across Latin America. In June, Vargas was featured at Roche's"Macular Spectacular" Ophthalmology Conference in Cartagena, Colombia, where he presented Vision AI as a cost-effective screening tool that can prevent diabetic blindness and improve health access in low-resource settings. He also highlighted a Q4 2024 pilot with Roche and Salud 360 that could scale across the U.S., Canada, and Europe if successful. Meanwhile, Vision AI has gone live through Grupo Dökka's Fischel and La Bomba pharmacy chains, offering walk-in screenings, real-time AI results, and direct referrals to care providers. The model eliminates the need for onsite ophthalmologists and is gaining traction with pharmacy chains, insurers, and life sciences partners. Avant and Ainnova's FDA engagement follows an earlier pre-submission meeting in July, where the agency provided clear guidance on study design and compliance. The refined clinical trial protocol, once greenlit, will guide a formal U.S. study aimed at supporting FDA clearance to market Vision AI domestically. Avant maintains global licensing rights to Ainnova's platform through Ai-nova Acquisition Corp., the JV established to commercialize Ainnova's technology portfolio. U.S. entry is viewed as a major inflection point with significant commercial potential. 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. Avant has also signaled plans for a dedicated therapeutic-focused spinout and continues to evaluate a full acquisition of Ainnova Tech under a previously announced non-binding LOI—potentially consolidating all assets and leadership under a single public platform. Renovaro Inc. (NASDAQ: RENB) secured multiple U.S. patents for its federated AI learning technologies in biomedical research. "Expanding our IP footprint in federated learning and AI-based data harmonization directly supports our long-term vision: to be the platform of choice for next-generation biomedical research and precision medicine," said David Weinstein, CEO, Renovaro. These patents support secure, privacy-preserving data integration across hospitals and labs for applications in drug discovery and precision medicine. The move strengthens Renovaro's position in the $20 billion biomedical AI space. Healthcare Triangle, Inc. (NASDAQ: HCTI) recently signed major contracts with large U.S. hospital systems and expanded its AI-powered EHR services. Its platform converts unstructured medical documents into usable data for clinicians. "These strategic wins reflect our ability to deliver enterprise-scale transformation with speed and precision," said Sujatha Ramesh, Chief Operating Officer of Healthcare Triangle." We're driving digital maturity, operational efficiency, and cost-effective care delivery - firmly positioning HCTI as a mission-critical partner, not just a service provider." The company is focused on making EHR systems smarter, more efficient, and better suited to community health networks. GE HealthCare Technologies Inc. (NASDAQ: GEHC) launched its Definium Pace Select ET, an AI-powered digital X-ray system for high-volume medical settings. "This launch reinforces our commitment to provide accessible, efficient, and high-quality care for patients, while alleviating stress from the technologist's workday by minimizing repetitive tasks and automating steps," said Jyoti Gupta, PhD, President and CEO of Women's Health and X-ray at GE HealthCare. "We remain dedicated to advancing our technology through transformative digital and AI-enabled capabilities that will remove barriers to timely and effective diagnostic imaging for any patient in need of X-ray imaging." The system automates repetitive tasks and improves image consistency to help radiologists work more efficiently. It's designed to relieve staffing pressures while maintaining high imaging standards in busy hospitals. Spectral AI, Inc. (NASDAQ: MDAI) submitted its DeepView System to the FDA for marketing approval under the De Novo pathway. "This FDA submission is a major milestone for Spectral AI and the DeepView System, representing a crucial step toward bringing this innovative diagnostic device to market in the United States," said Dr. J. Michael DiMaio, MD, Chairman of the Board at Spectral AI. "It provides clinicians with an immediate, data-driven assessment tool designed to assist clinical decision-making and may significantly improve patient outcomes." The device uses multispectral imaging and AI to predict how burn wounds will heal, helping doctors make faster and more accurate treatment decisions. It's positioned as a first-of-its-kind diagnostic tool in burn care. 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. Equity Insider is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media 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 MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves 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 MIQ 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. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Cision Canada
2 days ago
- Business
- Cision Canada
Avant Technologies and Ainnova Tech Advance Clinical Trial Protocol Following FDA Feedback
LAS VEGAS, July 29, 2025 /CNW/ -- Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced an update on the Company's clinical trial protocol following a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA). Following its mid-July meeting with the FDA, Ainnova has revised its clinical trial protocol with the FDA's comments in mind. The new protocol will be resubmitted for FDA review to ensure compliance, which will mitigate potential costly errors in the development process for Ainnova's planned trial for its Vision AI platform in the early detection of diabetic retinopathy. Late last week, Ainnova's clinical development team met with Fortrea, the Company's Contract Research Organization, to present the updated protocol document. Upon approval, this protocol will pave the way for the initiation of a new clinical trial aligned with the revised guidelines. "We are committed to meeting the highest regulatory standards, and we're confident that these protocol refinements will strengthen our path toward FDA 510(k) clearance," said Vinicio Vargas, Chief Executive Officer 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 anticipate finalizing the clinical trial budget soon, with estimated costs coming more into focus as we refine our protocol and navigate the process." The company remains focused on advancing its innovative Vision AI platform to address the early detection of diabetic retinopathy, with the goal of achieving FDA 510(k) approval to obtain clearance from the FDA to market its Vision AI technology in the U.S. and deliver transformative solutions to the market. AAC has the worldwide licensing rights for Ainnova's technology portfolio. The licensing rights include the U.S., where the FDA regulates drug and medical device development, so the success of Ainnova's clinical trial is paramount to marketing the technology portfolio in the United States. Entering the U.S. market will unlock significant commercial potential, and this early engagement with the FDA ensures AAC can do so with speed, credibility, and a validated product. 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.
Cision Canada
22-07-2025
- Business
- Cision Canada
From Diagnosis to Surgery: How AI Tech Is Quietly Reshaping Healthcare Profits
VANCOUVER, BC, July 22, 2025 /CNW/ -- USA News Group News Commentary – The AI revolution in healthcare is fully underway, with the potential to save lives and money, but there's still more to come. Healthcare startups are already figuring out how to implement AI to multiply their patients, and chase profits, to the benefit of investors. More Americans than ever are utilizing AI to diagnose their health issues, as the adoption of AI tools is becoming the norm among medical professionals. Now the developers of these game-changing technologies are overcoming regulatory barriers and moving closer to implementation of their solutions in the real world. Among the players that are moving closer to major milestones include Avant Technologies, Inc. (OTCQB: AVAI), Agenus Inc. (NASDAQ: AGEN), Clover Health Investments, Corp. (NASDAQ: CLOV), Zimmer Biomet Holdings, Inc. (NYSE: ZBH), and Monogram Technologies Inc. (NASDAQ: MGRM). Currently, the AI in healthcare sector projected to surpass $110 billion by 2030. However, according to Accenture, artificial intelligence could unlock an additional $461 billion in value across healthcare by 2035—on top of a sector already projected to surpass $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. Agenus Inc. (NASDAQ: AGEN) has partnered with AI biotech firm Noetik to develop predictive biomarkers for its cancer immunotherapy combo BOT/BAL. "At Agenus, we are committed to transforming cancer care through scientific innovation and next-generation immunotherapies," said Dr. Garo Armen, Chairman and CEO of Agenus. "This collaboration with Noetik enables us to harness cutting-edge AI to better understand patient biology and tailor treatments more precisely." By using Noetik's advanced "virtual cell" models trained on massive tumor datasets, the collaboration aims to identify which patients are most likely to benefit from treatment. This could improve clinical trial outcomes and accelerate personalized cancer care using AI-driven insights Clover Health Investments, Corp. (NASDAQ: CLOV) recently launched a new pharmacy pilot program across New Jersey in partnership with IPC's iCare+ network. The initiative enables local pharmacies to use AI tools and real-time data to help seniors manage medications and reduce hospital visits. "This is more than a new program—it's a new model for how we support our New Jersey members," said Jamie Reynoso, CEO of Medicare Advantage at Clover Health. "By working with the pharmacists who are already embedded in our communities, we can deliver better care, deliver amazing customer experiences and support the independent businesses that keep New Jersey strong." It's part of Clover's strategy to deliver more personal, community-based healthcare while supporting independent pharmacies Zimmer Biomet Holdings, Inc. (NYSE: ZBH) has entered a definitive agreement to acquire Monogram Technologies Inc. (NASDAQ: MGRM) for approximately US$177 million in cash, with additional milestone-based payments up to US$12.37 per share. " Monogram's technology is a major leap forward, demonstrating our commitment to becoming the boldest and broadest innovator in surgical robotics and navigation," said Ivan Tornos, Chairman, President and CEO of Zimmer Biomet. "Upon closing, our customer-centric portfolio will consist of the most comprehensive and flexible technology ecosystem to support the varying preferences of a vast array of surgeons – now and into the future. With Monogram's proprietary technology, Zimmer Biomet has the potential to become the first company to deliver fully autonomous capabilities and redefine both the standard of care and the future of orthopedic surgery." The acquisition adds Monogram's semi- and fully autonomous orthopedic robotics to Zimmer Biomet's ROSA® platform, aiming to create the most comprehensive robotics suite in the orthopedic space. Monogram's FDA-cleared knee arthroplasty robot is expected to commercialize in 2027, with a fully autonomous version in development. "Since our inception, we have been singularly focused on advancing orthopedic robotics with technology designed to safely, efficiently and accurately support surgeons with total knee arthroplasty," said Benjamin Sexson, CEO of Monogram. "We are thrilled by the opportunity to add our technology to Zimmer Biomet's leading portfolio of surgical robotics, navigation solutions and trusted implants and to benefit from their deep industry expertise and global scale." Zimmer Biomet expects the deal to be accretive by 2028, supporting long-term growth in the high-demand surgical robotics market. 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. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Avant Technologies Inc. advertising and digital media 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 MIQ own shares of Avant Technologies Inc. which were purchased in the open market. MIQ reserves 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 MIQ 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. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.
Cision Canada
22-07-2025
- Business
- Cision Canada
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. Contact:
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
