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NEW YORK , Oct. 21, 2025 /PRNewswire/ -- Artificial intelligence (AI) is making inroads into every corner of medical technology, perhaps none more urgently than imaging. In breast cancer detection, where early diagnosis can mean the difference between life and death, AI-enhanced modalities present a chance to leap beyond the limits of mammography, tomosynthesis, and MRI. Globally, breast cancer remains one of the most common cancers in women. According to the World Health Organization (WHO), more than 2.3 million women were diagnosed with breast cancer in 2022, and approximately 670,000 women died from the disease globally. In the United States, the American Cancer Society (ACS) projects that 316,950 new invasive breast cancer cases will be diagnosed among women this year. The urgent, life-saving need for earlier and more accurate detection creates a powerful opportunity for innovation in diagnostic imaging. Amid this global challenge, companies advancing breast cancer diagnostics are entering a high-impact field. Among them, Izotropic Corporation(CSE: IZO) (OTCQB: IZOZF) (profile) stands out with its next-generation IzoView Breast CT Imaging System, a dedicated 3D imaging platform designed to improve detection accuracy, particularly for women with dense breast tissue. IzoView joins an elite group of companies, including Hologic Inc. (NASDAQ: HOLX), GE HealthCare Technologies Inc. (NASDAQ: GEHC), Nano-X Imaging Ltd. (NASDAQ: NNOX) and Oracle Corp. (NYSE: ORCL), that are focused on playing a transformative role in the use of AI in the medical imaging sector.

• Izotropic Corporation has advanced its plan to commercialize IzoView, a dedicated breast CT scanner purpose-built to address dense breast imaging, a high-priority and underserved segment.
• One of Izotropic's key selling points is that IzoView is engineered for economic scalability and extensibility.
• Izotropic's strategy relies on a proprietary AI image reconstruction algorithm, trained over 15 years of specialized breast CT data and held as a trade secret.
• Izotropic's vision for IzoView extends beyond imaging hardware; it is structured to become a node within the larger AI-enabled diagnostic ecosystem .
• According to analysts, the global breast imaging market is projected to grow at ~8.6% CAGR between 2023 and 2030, reaching approximately $9 billion by 2030.

Click here to view the custom infographic of the Izotropic Corporation editorial.

AI and 3D Imaging: The New Frontiers of Detection

The convergence of AI and three-dimensional (3D) medical imaging marks a turning point in diagnostic medicine. While traditional mammography has been a life-saving screening tool for decades, it is inherently constrained by its two-dimensional projection format and the physical compression required to visualize internal structures.

In dense breast tissue, present in more than one-half of women, lesions can be obscured or distorted, leading to reduced sensitivity and delayed detection. Research confirms that dense fibroglandular tissue can mask or mimic breast cancers, thereby lowering diagnostic accuracy and increasing the risk of missed cases, with one study reporting that mammography performance declines significantly in dense breasts, as overlapping tissue often conceals malignancies.

The emergence of AI-driven image reconstruction and analysis now offers a transformative solution to these long-standing challenges. Advanced algorithms can enhance contrast, reduce image noise and identify subtle patterns invisible to human interpretation. AI-based methods have also been shown to improve CT image quality while maintaining or reducing radiation dose, producing clearer and safer diagnostic results. In breast imaging specifically, recent reviews highlight that deep learning systems can augment or even match radiologist performance in lesion detection, segmentation and classification, particularly in dense tissue or early-stage disease.

This integration of AI with volumetric imaging technologies, such as tomosynthesis, MRI and dedicated breast CT, signals a broader shift toward intelligent diagnostics capable of generating and interpreting 3D data simultaneously. Radiology experts anticipate that AI will continue to revolutionize accuracy and efficiency across medical imaging, supporting clinicians in faster and more reliable decision-making.

Within this environment, Izotropic's IzoView Breast CT Imaging System is designed to operate between digital breast tomosynthesis and MRI, combining high-resolution volumetric imaging with proprietary AI reconstruction technology. Its trade-secret algorithm, built on more than a decade of specialized breast CT data, and its potential integration with future computer-aided diagnosis (CADx) tools position IzoView squarely at the frontier of AI-empowered breast cancer detection.

Commercializing IzoView for Dense Breasts

Izotropic Corporation has advanced its plan to commercialize IzoView, a dedicated breast CT scanner purpose-built to address dense breast imaging, a high-priority and underserved segment. Approximately 50% of women in the United States have dense breast tissue, complicating lesion visibility and increasing the risk of missed cancers. IzoView's design seeks to penetrate that gap through 3D volumetric imaging without compression and with improved contrast resolution.

In regulatory and market strategy documents, Izotropic positions IzoView as uniquely suited for dense tissue, citing literature and prototype research supporting breast CT in dense contexts. Because many women with dense breasts derive less benefit from standard mammography, regulatory guidelines and advocacy groups are driving calls for supplemental screening. That environment increases the addressable market for improved imaging modalities such as IzoView.

In investor presentations, the company emphasizes that IzoView could serve both screening and diagnostic workflows, initially launching and penetrating the market as a complement to tomosynthesis with MRI comparable imaging, before seeking regulatory approvals to replace these devices. IzoView's goal is to offer a platform that radiology clinics, breast centers, and hospitals can adopt for denser-breast populations while managing cost, workflow and integration. By focusing on this niche, Izotropic aims to align its commercialization roadmap with evolving medical guidelines and reimbursement pressure — a wise strategy for medtech entrants in specialty imaging.

Scalability, Modularity and Platform Potential

One of Izotropic's key selling points is that IzoView is engineered for economic scalability and extensibility. Public disclosures state a target device sale price of $500,000, compared to legacy breast CT systems whose list prices reach $1.5 million or more. This pricing ambition would enable more widespread adoption in distributed and outpatient imaging environments.

Izotropic has identified 14 Indications for Use (IFUs) in its roadmap, which support a strategy of recurring revenue via software upgrades, new imaging modes and evolving clinical applications across screening, diagnosis, monitoring, planning and personalized medicine. This modular model allows the hardware base to remain stable while functionality expands over time.

The system's modular engineering also supports deployment in high-throughput settings and decentralized care facilities. Designed to be self-shielded (no need for specialized radiation shielding infrastructure) and with streamlined patient workflows, the platform reduces barriers to entry in smaller clinics or regional hospitals. This opens global market opportunities where heavy infrastructure, such as MRI suites and shielding rooms, may be cost prohibitive.

By combining a competitive device cost, upgradeable architecture and multi-indication expansion, Izotropic positions IzoView not just as a scanner but as a platform — a base for future growth and differentiation.

Durable Advantage in AI Reconstruction

In the AI/medical imaging domain, many innovations gravitate toward commoditization; algorithms get replicated, open-source models get tuned and differentiation narrows. Izotropic's strategy counters that by relying on a proprietary AI image reconstruction algorithm, trained over 15 years of specialized breast CT data, held as a trade secret. In a market where many vendors share or license similar models, that kind of unique dataset and refinement can yield a durable competitive advantage.

The algorithm enables denoised, optimized CT images while maintaining low radiation doses comparable to 2-view mammography, a critical balance in breast imaging where radiation exposure is always a constraint. This combination of low-dose imaging, optimized reconstruction and image fidelity is a key value driver when integrating downstream diagnostic AI. Indeed, the better the input data, the better any CADx or decision support tool can perform.

Furthermore, the trade-secret nature of the model helps avoid easy imitation or copying by rivals that rely exclusively on public AI frameworks. This creates a barrier to entry and helps Izotropic maintain a technological moat. Over time, as clinical validation matures, integration with diagnostic AI on top of that reconstruction backbone could deepen that moat further.

Platform Integration, AI Ecosystem Synergy

Izotropic's vision for IzoView extends beyond imaging hardware; it is structured to become a node within the larger AI-enabled diagnostic ecosystem. The company holds exclusive rights to a patented computer-aided diagnosis (CADx) module for breast CT, positioning itself to deliver not just images but interpretation and triage.

As imaging modalities converge with analytics and cloud infrastructure, IzoView's high-quality volumetric datasets become valuable training ground for AI partners. Radiology groups increasingly seek platforms that not only image but help clinicians interpret, prioritize and act on findings.

Because IzoView produces 3D volumetric data rather than 2D images, it can feed more robust datasets for AI training, including richer spatial context, finer lesion delineation and better volumetric metrics. This gives Izotropic leverage when negotiating partnerships, data collaborations and AI licensing arrangements. Over time, the device could act as a gateway for third-party clinical decision tools built on its imaging foundation.

High-Growth Market and Strategic Positioning

The market opportunity supporting Izotropic is large — and expanding. According to analysts, the global breast imaging market is projected to grow at ~8.6% CAGR between 2023 and 2030, reaching approximately $9 billion by 2030. Other forecasts estimate a market of $5.21 billion in 2024 to $10.37 billion by 2032, with a CAGR of 8.97%. In itself, that trajectory demonstrates robust demand for next-gen modalities.

Regional breakdowns suggest North America will remain a leading market, driving adoption and reimbursement trends. Izotropic's own disclosures cite projections in digital breast tomosynthesis (DBT) growing from $950 million in 2024 to $USD 1.71 billion in 2030, showing a CAGR of ~10.28%.

Izotropic is advancing a regulatory strategy aligned with the FDA, pursuing a modular PMA (premarket approval) pathway and staged clinical data submissions. The company also publishes milestone roadmaps for its commercial launch plan. With a differentiated technology, trade-secret AI, CADx potential and scalable business model, Izotropic is well positioned to compete in a high-growth imaging market as long as the company can deliver on clinical validation, regulatory approval, and adoption by imaging centers.

Leaders Harness AI to Revolutionize Screening, Diagnosis

Artificial intelligence is rapidly reshaping the cancer-imaging field, enhancing the accuracy and efficiency of screening and diagnostics. Recent advancements in AI-powered imaging and 3D technologies are improving detection of aggressive cancers, streamlining workflows and expanding access to advanced imaging services across multiple care settings. These innovations promise to provide deeper insights into tumor biology and support more personalized approaches to patient care.

Hologic Inc.  presented data from two groundbreaking studies evaluating the performance of the company's artificial intelligence (AI)-powered mammography technology at this year's European Society of Breast Imaging (EUSOBI) Annual Scientific Meeting in Aberdeen, Scotland. The data suggests that AI may help identify more aggressive breast cancers and perform comparably to experts in breast cancer screening. "These results underscore AI's ability to make breast cancer screening more accurate and efficient, and its potential to provide valuable insights about each patient's unique tumor biology," said Mark Horvath, president, Breast and Skeletal Health Solutions at Hologic. "

GE HealthCare Technologies Inc.  has launched Invenia(TM) Automated Breast Ultrasound (ABUS) Premium. The system is the latest 3D ultrasound offering advanced AI and innovative features to drive faster, reproducible supplemental screening and streamline exam readings on patients with dense breasts. There is growing evidence supporting ABUS as a valuable tool for detecting cancer in dense breasts because it provides clearer and more detailed images and has been shown to improve the sensitivity of detecting invasive cancer in dense breasts when added to mammography.

Nano-X Imaging Ltd.  announced a collaboration between its U.S. subsidiary Nanox Impact Inc. and Monarch Medical Management and Billing LLC. As part of the collaboration, Nanox will establish a comprehensive imaging network by deploying its technology across Monarch's associated healthcare facilities, including nursing homes, outpatient clinics and dedicated imaging centers for workers' compensation cases. Monarch has identified more than a dozen initial sites that will undergo a proof-of-concept phase, after which Nanox intends to expand the network nationwide. The collaboration will provide patients across multiple care settings with access to advanced imaging services.

Oracle Corp.  has partnered with Imagene, a pioneer in AI-based precision oncology, to announced CanvOI. Running on Oracle Cloud Infrastructure (OCI), CanvOI is a state-of-the-art pan-cancer foundation model designed to facilitate innovative research and development in the digital pathology and oncology space. The system captures the complex features and patterns within biopsy images, providing valuable oncology intelligence that could improve the way cancer is diagnosed and treated around the world. It also delivers a robust vision data backbone for the development of downstream applications in oncology research, including predicting treatment responses, discovering biomarkers, assessing disease prognosis and identifying pathological features with state-of-the-art results.

These innovations signal a new era in cancer imaging, where AI and advanced imaging technologies are not only increasing diagnostic accuracy but also streamlining workflows and expanding access to care. From improving breast cancer detection to enabling sophisticated digital pathology research, these developments highlight the potential for AI to fundamentally transform cancer diagnosis and treatment, offering hope for more personalized, efficient and effective patient care worldwide.

For further information about Izotropic Corporation, please visit the Izotropic Corporation profile.

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