The FDA’s Quiet AI Pivot May Trigger the Next Major Investment Cycle in Healthtech

Issued on behalf of Avant Technologies Inc.

VANCOUVER – Baystreet.ca News Commentary – The U.S. Food and Drug Administration (FDA) gave another major boost to the use of Artificial Intelligence (AI) in healthcare through the full deployment of AI internally on June 30. The move came after the completion of a new generative AI pilot for scientific reviewers, which would allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that slow down the review process. This is another signal that AI-enhanced healthcare is inevitable, with MarketsandMarkets forecasting the AI in Healthcare Market to surge at a massive 38.6% CAGR to an impressive US$110.61 billion by 2030. With the FDA bringing AI in-house for its own needs, there appear to be several other AI solutions being developed across healthcare, by innovators such as Avant Technologies, Inc. (OTCQB: AVAI), Spectral AI, Inc. (NASDAQ: MDAI), CareCloud, Inc. (NASDAQ: CCLD, CCLDO), Zimmer Biomet Holdings, Inc. (NYSE: ZBH), and Medtronic plc (NYSE: MDT).

Serious capital is flowing into the AI healthcare space, with private healthcare innovator Persivia recently receiving $107 million to expand its AI-driven healthcare platform. By 2035, analysts believe AI could add another $461 billion in value to a healthcare industry already on track to surpass $2.26 trillion.

Avant Technologies and Ainnova Tech Begin Acquisition Talks Ahead of FDA Pre-Submission Meeting

Avant Technologies, Inc. (OTCQB: AVAI), an emerging player in AI-driven healthcare innovation, and its JV partner, Ainnova Tech, Inc., (Ainnova), a leading healthcare technology company focused on revolutionizing early disease detection using artificial intelligence (AI), today announced the companies and their advisors have entered into negotiations for an acquisition to better compete in the rapidly changing global AI-driven healthcare industry.

Six months ago, the two companies formed Ai-nova Acquisition Corp. (AAC) to advance and commercialize Ainnova’s technology portfolio, including its Vision AI platform and its versatile retinal cameras. During that time, the two companies completed further due diligence and focused on an opportunity to work together as one company. The Board of Directors and management team of Avant remain fully committed to executing the Company’s strategic plan, which is focused on enhancing long-term value. Leadership at Avant expects the negotiations to move forward with an acquisition of Ainnova.

Both Avant and Ainnova agree that the time is now to solidify the relationship and move forward as one entity prior to their pre-submission meeting with the U.S. Food and Drug Administration in July for the planned clinical trial of its Vision AI platform in the early detection of diabetic retinopathy.

Vinicio Vargas, Chief Executive Officer at Ainnova and a member of the Board of Directors of Ai-nova Acquisition Corp., said of the negotiations, “We believe bringing the two companies together will offer tremendous value for shareholders, it will simplify the process of advancing our technology to market, and it will deliver value to our customers and partners as we promote our technology portfolio globally.

We feel the joint venture has been a success and both companies have worked well together toward a common goal, so we believe that we can be even more successful and use our resources more effectively as one company to further AI in healthcare.”

Currently, 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 both companies expect that an acquisition will unlock growth opportunities and drive sustained performance as both entities plan to interact with the FDA in July for an upcoming clinical trial working even more closely together under one banner.

Vargas continued, “The success of our interactions with the FDA are crucial to our success in the clinic and eventually the success of marketing our technology portfolio in the United States and around the world. Entering the U.S. market will unlock significant commercial potential, and this early engagement with the FDA ensures that we can do so with speed, credibility, and a validated product.”

This announcement marks a major step forward in the relationship between Avant Technologies Inc. (OTCQB: AVAI) and Ainnova Tech, as they move to unify operations under one banner ahead of their anticipated FDA meeting this July. The companies already operate together under AAC, the joint venture that holds global rights to Vision AI—a non-invasive screening platform designed to flag early signs of serious chronic conditions through a combination of retinal imaging, vital sign capture, and AI algorithms.

With a U.S. clinical trial on the horizon, the timing of this acquisition discussion is notable. A finalized deal could simplify decision-making, streamline regulatory filings, and increase alignment across teams as they work to bring Vision AI to the U.S. healthcare market under a 510(k) pathway. The upcoming FDA meeting is a key step in that process, helping to define the clinical roadmap needed to support clearance.

While most early-stage healthcare AI companies remain pre-commercial, Avant’s technology is already live in multiple countries across Latin America, including Chile, Brazil, and Mexico. These real-world deployments are generating valuable patient data and demonstrating how early detection tools can lower costs and improve outcomes in routine clinical settings.

The company has also recently added four new diagnostic algorithms to its portfolio, trained on more than 2.3 million clinical cases and integrated into the Vision AI platform to improve accuracy across a wider range of chronic conditions. With early traction, regulatory momentum, and a potential acquisition in motion, Avant Technologies is becoming a small-cap AI healthcare story that investors are watching more closely.

CONTINUED… Read this and more news for Avant Technologies Inc. https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/

Spectral AI, Inc. (NASDAQ: MDAI) recently presented new clinical data at the American Burn Association meeting, showcasing over 95% accuracy in predicting burn healing potential with its AI-driven DeepView® System. The device uses multispectral imaging and machine learning to help clinicians assess wound recovery before symptoms worsen. Already in use at several NHS hospitals in the UK, DeepView is gaining traction as a real-world AI diagnostic tool in acute care.

“From our initial studies, the DeepView® technology is showing over 95% overall accuracy when predicting healing potential in a burn wound by 21 days,” said Leslie Tan, Burn and Plastics Senior Registrar of Newcastle Burns Centre. “[This accuracy] is one of the highest I’ve seen amongst the machines I’ve evaluated over the last few years.”

CareCloud, Inc. (NASDAQ: CCLD, CCLDO) recently reported strong Q1 2025 results while launching its new AI Center of Excellence, which is on track to house 500 healthcare AI specialists by year-end. The initiative is focused on automating clinical workflows, optimizing revenue cycle operations, and improving patient outcomes, all while being self-funded through operating cash flow. As one of the few small-cap players scaling generative AI across administrative and clinical functions, CareCloud is gaining attention for its disciplined, cash-positive expansion.

"By building one of the largest dedicated healthcare AI teams globally, we believe we are creating real-world solutions to automate clinical workflows, optimize revenue cycle management, and improve patient outcomes," said A. Hadi Chaudhry, Co-CEO of CareCloud. "This initiative is intended to accelerate our operational efficiency as well as positioning CareCloud at the forefront of intelligent healthcare transformation — driving sustainable profitability and long-term growth for ourselves and the healthcare providers who use our services."

At AAOS 2025, Zimmer Biomet Holdings, Inc. (NYSE: ZBH) highlighted its growing portfolio of AI-powered surgical tools, including OrthoGrid Hip AI® and HipInsight™, which provide real-time intraoperative guidance. The company also showcased Persona IQ®, a smart knee implant that transmits recovery data directly from the joint to the care team.

"We are in the midst of one of the largest innovation cycles in our company's history," said Ivan Tornos, President and CEO at Zimmer Biomet. "Our broad hip reconstruction portfolio combined with our comprehensive knee portfolio with constructs designed to safeguard against cement and metal sensitivities, our bone-preserving stemless shoulder and now an enhanced suite of ASC solutions, squarely position us at the forefront of delivering customer-centric innovations to improve efficiency and overall patient outcomes."

These technologies demonstrate how AI is being woven into orthopedic procedures to improve accuracy, reduce strain, and personalize recovery. As digital health and robotics converge in surgery, Zimmer Biomet’s approach signals how legacy medtech leaders are adapting to the AI-driven future of care.

Medtronic plc (NYSE: MDT) recently shared new clinical results for its Affera™ AI-integrated ablation platform at the Heart Rhythm Society 2025 meeting, highlighting strong safety and efficacy in treating atrial fibrillation.

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel, president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

The investigational Sphere-360™ catheter demonstrated 88% freedom from arrhythmia recurrence and 98% durable isolation in a multicenter European trial. With integrated mapping, dual-energy capabilities, and an upcoming U.S. pivotal trial, Affera is shaping up to be a major leap forward in precision electrophysiology.

Source: https://usanewsgroup.com/2023/10/26/unlocking-the-trillion-dollar-ai-market-what-investors-need-to-know/

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