FDA Watch: The Quiet Gold Rush in AI-Powered Medical Devices
Equity Insider News Commentary
Issued on behalf of Avant Technologies Inc.
VANCOUVER, BC, April 2, 2025 /PRNewswire/ -- Equity Insider News Commentary – Artificial Intelligence (AI) is quickly becoming a major force in healthcare, as use of AI applications in medical fields is growing rapidly. Researchers at Dartmouth recently conducted the first clinical trial of a therapy chatbot powered by generative AI (genAI), and found that it resulted in significant improvements in participants' symptoms. Cleveland Clinic and UAE-based G42 recently started collaborating on the advancement of even more AI in healthcare adoption, signalling an international push in this revolution. Because of this, the market is paying even more attention to developers in tech that are adding tools to the mix, with recent updates coming from Avant Technologies, Inc. (OTCQB: AVAI), Apple Inc. (NASDAQ: AAPL), Amazon.com, Inc. (NASDAQ: AMZN), Spectral AI, Inc. (NASDAQ: MDAI), and GE HealthCare Technologies Inc. (NASDAQ: GEHC).
The article continued: Billionaire Bill Gates recently predicted that he thinks AI will make medical advice free and commonplace, changing healthcare at a rapid pace along the way. Private company Layer Health just raised a fresh $21 million to take on Healthcare AI's scalability challenges, with investment from Define Ventures, Flare Capital Partners, GV and MultiCare Capital Partners.
Avant Technologies Partner, Ainnova, to Sponsor and Present at 2025 Healthcare Innovation Summit in Mexico City
Avant Technologies, Inc. (OTCQB: AVAI), an emerging leader in AI-driven healthcare innovation, continues to build momentum in the AI-driven healthcare sector through its joint venture with Ainnova Tech, developers of the Vision AI platform. Today, the two companies announced that Ainnova will sponsor and present at the 2025 Mexico Healthcare Innovation Summit—an international event focused on digital transformation and diagnostics.
Ainnova's CEO, Vinicio Vargas, will present on preventative healthcare powered by artificial intelligence, highlighting the practical impact of its Vision AI platform on early disease detection, which the company recently began designing the clinical trial protocols for ahead of a pre-submission meeting with the US Food and Drug Administration (FDA).
Vargas's appearance at the event reinforces a consistent strategy for Avant and Ainnova: increasing visibility across key international markets ahead of major regulatory milestones to come.
It also follows Ainnova's recent strategic alignment with Apollo Hospitals in Southeast Asia, where the Vision AI platform has been cleared for commercial deployment in Brazil, and clinical pilots are being prepared across the Americas.
As previously mentiond, Ainnova is being guided by global CRO Fortrea ahead of the important pre-submission meeting with the FDA. The goal is to seek 510(k) clearance for Vision AI in detecting diabetic retinopathy, a gateway to broader use across multiple chronic disease categories.
Avant and Ainnova jointly control Ai-nova Acquisition Corp. (AAC), which holds global licensing rights to the technology portfolio, including proprietary retinal cameras and algorithms validated on more than 2.3 million clinical data points.
Between FDA progress, high-profile alliances, and a growing international presence, Avant Technologies continues to carve out a niche in the convergence of AI, diagnostics, and preventative care. Investors looking for small-cap exposure to the healthcare AI revolution may want to keep AVAI on the radar as these developments unfold.
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Apple Inc. (NASDAQ: AAPL) is reportedly working on an AI-driven health coach, under the codename Project Mulberry, as a revamped version of its Health app. For a while now, CEO Tim Cook has been promising that Apple's long-term plans include a big push into more health-related technologies.
According to Bloomberg's Mark Gurman, Apple could launch this as early as next year alongside a future iOS update. The service would give users tips on diet and exercise, using data from the Health app and Apple devices like the Apple Watch.
It's still unclear whether this tool will act more like a real medical assistant or just a health and wellness coach. Gurman describes it as an "AI doctor service," and the report says it's being trained using real data from doctors and medical professionals. The service might be called Health Plus and could become a major part of Apple's growing services business.
Amazon.com, Inc. (NASDAQ: AMZN) is pushing deeper into genAI itself, including testing health assistants with a chatbot tool focused on health and wellness, called Health AI, which can answer health and wellness questions, "provide common care options for health care needs," and suggest products.
Already, Amazon's shopping chatbot, Rufus, can suggest products like ice packs and ibuprofen. Where Health AI goes further will be in providing users with medical guidance and care tips, such as how to deal with flu or cold symptoms. Health AI also steers users to Amazon's online pharmacy, along with clinical services offered by One Medical, the primary care provider it acquired for roughly $3.9 billion in 2022.
Spectral AI, Inc. (NASDAQ: MDAI) recently announced strong results from its Burn Validation Study, showing that its DeepView® System outperformed burn physicians in identifying non-healing tissue.
"We believe these are excellent results and we are thrilled with the analysis of our DeepView System in our Burn Validation Study," said Dr J. Michael DiMaio, M.D. "The DeepView System exceeded our expectations in terms of predictive performance. Following the FDA's review, if authorized by the agency, our hope is that this tool will provide an objective and immediate prediction of non-healing burn tissue to expedite patient care and reduce system costs across the board. We look forward to bringing this predictive diagnostic tool to the United States marketplace as soon as possible."
The study, one of the largest of its kind in the U.S., demonstrated DeepView's superior accuracy using AI and multispectral imaging to assess burn wounds on day one. The company plans to submit the data to the FDA by mid-2025, aiming for De Novo Clearance and rapid commercialization.
GE HealthCare Technologies Inc. (NASDAQ: GEHC) recently unveiled its new Revolution™ Vibe CT system, featuring advanced AI-powered cardiac imaging that delivers fast, accurate scans—even in complex cases like atrial fibrillation or heavy coronary calcification. The system's Unlimited One-Beat Cardiac imaging and AI-driven workflow aim to improve diagnostic speed, patient comfort, and operational efficiency across healthcare facilities.
"Expanding access to CCTA is crucial for managing the rising prevalence of CVD, ensuring timely and accurate diagnoses for a larger patient population," shares Jean-Luc Procaccini, President and CEO, Molecular Imaging and Computed Tomography, GE HealthCare. "Our introduction of Revolution Vibe underscores our commitment to this mission. The system is designed to encourage the broader adoption of and access to cardiac imaging, combining advanced technology with AI-powered solutions to deliver fast, accurate diagnoses and a more comfortable patient experience. It is designed to empower healthcare providers to offer the highest quality care, even in the most challenging cases."
With FDA-recommended CCTA adoption on the rise and cardiac disease still the leading global cause of death, Revolution Vibe is designed to expand access to life-saving imaging and reduce reliance on invasive procedures.
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