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.
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Vision, Velocity, and Validation: The AI Platform Moving Toward FDA and Global Scale
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 Readeable.AI 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.
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