AI Healthcare Boom Gains Speed as Regulators and Innovators Align

Equity Insider News Commentary

Issued on behalf of Avant Technologies Inc.

VANCOUVER, BC, May 5, 2025 /CNW/ --The integration of artificial intelligence (AI) into healthcare is here to stay, and adoption is accelerating. According to research from PYMNTS Intelligence which polled C-suite executives at healthcare companies generating at least $1 billion in annual revenue, 90% already see positive ROI from investments in generative AI (GenAI). Analysts are projecting that by 2035 the gross value added by AI to the healthcare industry will be $461 billion on top of a baseline $2.26 trillion. Behind the scenes, several new AI healthcare tech developments are taking place, with updates recently coming from Avant Technologies, Inc. (OTCQB: AVAI), Tempus AI, Inc. (NASDAQ: TEM), Tevogen Bio Holdings Inc. (NASDAQ: TVGN), GE HealthCare Technologies Inc. (NASDAQ: GEHC), and Schrödinger, Inc. (NASDAQ: SDGR).

At the regulatory level, the World Health Organization (WHO) recently announced a major global initiative to set unified standards for AI in healthcare, the US Food and Drug Administration (FDA) is working to catch up on approving new AI tech in the sector, with the latest being a cardioverter defibrillator.

Avant Technologies, Inc. (OTCQB: AVAI), an emerging leader in AI-driven healthcare innovation, continues to accelerate its push into AI-powered healthcare diagnostics through its joint venture with Ainnova Tech, operating through Ai-nova Acquisition Corp. (AAC), a jointly controlled entity that holds global licensing rights to VisionAI and its supporting hardware. The two companies recently announced that the FDA has officially received their request for a pre-submission meeting for VisionAI, the joint venture's flagship screening platform.

This marked a pivotal moment in Avant's trajectory. VisionAI uses a combination of retinal imaging, patient vitals, and advanced algorithms to identify early warning signs of diabetic retinopathy, cardiovascular disease, liver fibrosis, kidney disease, and type 2 diabetes—often before symptoms are visible. Studies show that AI tools can detect diabetic retinopathy and other chronic conditions with sensitivities exceeding 90%, often identifying issues before symptoms appear—according to NIH.

"This milestone reflects our two-tiered strategy, rapid deployment in low-regulation markets where VisionAI operates as a screening tool, and simultaneous progress toward FDA clearance for the U.S. market," said Vinicio Vargas, CEO at Ainnova and a member of AAC's Board of Directors. "Entering the U.S. will unlock significant commercial potential, and early engagement with regulators ensures we do so with speed, credibility, and a validated product."

The upcoming FDA meeting will help finalize the clinical trial design and confirm the regulatory pathway for a 510(k) submission in the U.S., setting the stage for broader deployment.

What sets AVAI apart from many AI-in-healthcare names is that its technology is already in the field. VisionAI has been rolled out through commercial pilot programs across Latin America, including Chile, the Dominican Republic, Mexico, and Brazil. These early deployments are generating real-world data while demonstrating how early diagnostics can reduce system-wide costs and improve outcomes in primary care environments.

In recent months, AAC expanded its portfolio with four newly licensed diagnostic algorithms from one of Asia's largest healthcare networks, validated on more than 2.3 million clinical cases. These models are now integrated into VisionAI to enhance its detection capabilities across multiple chronic disease categories.

On the clinical development front, Avant's partner Ainnova has brought on global contract research organization Fortrea to help guide its FDA strategy. With both emerging-market traction and U.S. regulatory progress advancing in parallel, the company appears to be executing on a dual-pronged strategy: building early market access where regulatory barriers are lower, while preparing for the commercial scale and reimbursement potential of the U.S. healthcare system.

For investors tracking small-cap companies operating at the intersection of AI, diagnostics, and chronic disease management, Avant Technologies may be worth a closer look. As the FDA process moves forward and pilot programs scale, AVAI sits in a rare position—commercially active, globally licensed, and now formally in dialogue with U.S. regulators.

Tempus AI, Inc. (NASDAQ: TEM) recently expanded its support for phase I clinical trials by launching the TIME Precision Network, a group of investigators across over 40 research centers focused on rapid activation and enrollment.

"The integration of phase I clinical trial sites adds a critical capability to the TIME Network,"said Ezra Cohen, MD, Chief Medical Officer, Oncology at Tempus.  "We are now able to activate and efficiently execute these early studies that are fundamental to drug development and such a valuable offering to patients. The reality is that these studies require specific and coordinated infrastructure to be successful, and I am proud that Tempus can now work with these sites and our life science partners to enroll patients into these cutting-edge clinical trials."

Recent examples include first-patient-in enrollments within weeks at multiple cancer centers, showcasing the network's efficiency in matching patients to studies. By integrating community oncology sites and streamlining site activation, Tempus is lowering access barriers to early-stage trials across underserved regions.

Tevogen Bio Holdings Inc. (NASDAQ: TVGN) is advancing its AI-driven precision medicine capabilities through a new partnership with Databricks, focused on accelerating the development of its PredicTcell platform. The collaboration will enhance Tevogen's ability to model immunologically active peptide complexes and predict T cell receptor (TCR) engagement.

This builds on the company's ExacTcell™ platform and complements other strategic alliances under the Tevogen.AI umbrella, including support from Microsoft Research. Together, these efforts aim to integrate clinical immunology with cutting-edge AI to fast-track the discovery and development of next-generation T cell therapies.

GE HealthCare Technologies Inc. (NASDAQ: GEHC) is deepening its commitment to AI-driven oncology solutions with the launch of MR Contour DL, a new FDA-cleared model for organ segmentation in radiation therapy planning.

"We're committed to advancing MR imaging capabilities in radiation therapy to deliver more accurate and precise care," said Kelly Londy, President and CEO, MR, GE HealthCare. "The anticipated addition of Spectronic's software offering to our portfolio would support our vision for an MR-based radiation oncology workflow and would help enable high-precision treatment planning for radiotherapy patients across the globe."

The company also announced its intent to integrate Spectronic Medical's MRI Planner software to support MR-only workflows across global radiotherapy centers. These tools are being folded into the expanded Intelligent Radiation Therapy (iRT) solution, which now supports third-party AI applications and accelerates the treatment timeline. By combining MR imaging, automation, and deep learning, GE HealthCare aims to raise the precision and accessibility of radiotherapy worldwide.

Schrödinger, Inc. (NASDAQ: SDGR) recently presented new preclinical data at AACR 2025 on two targeted cancer therapies developed using its proprietary computational platform. Among the findings, a machine learning model predicted synergistic drug combinations for its Wee1 inhibitor SGR-3515, enhancing its potential use across multiple tumor types.

"The preclinical data for SGR-3515 and SGR-4174 further demonstrate that molecules discovered and developed by Schrödinger have favorably differentiated molecular profiles compared to existing development-stage molecules," said Karen Akinsanya, Ph.D, President of R&D therapeutics at Schrödinger. "The preclinical profiles of these development candidates reinforce the power of our computationally-driven approach to designing molecules that meet challenging target product profiles and have the potential for meaningful benefit to patients."

The company's AI-driven discovery approach continues to yield differentiated molecules with promising therapeutic profiles.

As AI continues to evolve from concept to clinical application, these companies are quietly shaping the future of medicine at the infrastructure level. With regulatory momentum building and real-world deployments expanding, investors may want to pay attention as this shift begins to accelerate.

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