Biharmonic Imaging Breakthroughs: 2025 Ultrasound Market’s Hidden Goldmine Revealed!

Table of Contents

• Executive Summary: Key Findings and 2025 Outlook
• What is Biharmonic Imaging? Technology Fundamentals Explained
• Major Players & Innovators: Company Strategies and R&D Initiatives
• Current Applications: Biharmonic Imaging in Clinical Ultrasound
• Emerging Use Cases: From Oncology to Cardiology
• Market Size and Growth Forecasts: 2025–2030
• Regulatory Pathways & Standards (FDA, IEC, IEEE)
• Barriers to Adoption: Technical, Economic, and Clinical Hurdles
• Investment & Partnership Trends: Venture Capital and Alliances
• Future Outlook: Next 3–5 Years of Disruptive Innovation and Adoption
• Sources & References

Executive Summary: Key Findings and 2025 Outlook

Biharmonic imaging represents a significant advance in biomedical ultrasound, leveraging the nonlinear propagation of acoustic waves to enhance image resolution and tissue characterization. As of 2025, this technology is moving from academic research towards broader clinical evaluation and early-stage adoption, driven by the demand for more precise, non-invasive diagnostic tools.

Key findings in 2025 indicate that leading ultrasound manufacturers are actively exploring or piloting biharmonic imaging modalities. GE HealthCare and Siemens Healthineers, both recognized for pioneering medical imaging solutions, have initiated collaborative research projects with clinical and academic partners to test biharmonic and other multi-frequency techniques in liver, vascular, and breast imaging. Preliminary data from these trials suggest improvements in contrast-to-noise ratio and lesion detectability, particularly for challenging cases such as fibrosis staging and microvascular assessments.

Research centers in partnership with major industry players—including Philips Healthcare—are focusing on algorithm development for real-time biharmonic signal processing. These efforts are supported by advances in transducer design and computing hardware, enabling the capture and analysis of complex frequency interactions within biological tissues. Early 2025 prototype systems have demonstrated the potential to distinguish subtle tissue pathologies with greater specificity compared to conventional harmonic imaging, paving the way for improved diagnostic confidence and patient outcomes.

Notably, regulatory bodies such as the U.S. Food and Drug Administration (FDA) are engaging with device makers to establish performance and safety standards for next-generation ultrasound modalities, including biharmonic approaches. This regulatory attention is expected to accelerate clinical translation, with several investigational device exemptions and pilot studies underway in North America, Europe, and Asia.

Looking ahead, the outlook for biharmonic imaging in 2025 and beyond is marked by cautious optimism. The next few years will likely see expanded multi-center clinical trials, further hardware refinements, and algorithmic improvements to support workflow integration in radiology and point-of-care settings. Industry leaders are also exploring the application of biharmonic techniques in contrast-enhanced ultrasound and targeted therapies, hinting at a broader transformative impact across diagnostic and interventional domains.

Overall, biharmonic imaging is positioned as a key innovation within biomedical ultrasound, with momentum building for its adoption as both a research tool and a future clinical standard.

What is Biharmonic Imaging? Technology Fundamentals Explained

Biharmonic imaging is an advanced ultrasound technique leveraging the non-linear propagation of acoustic waves to improve the quality and diagnostic value of biomedical imaging. Unlike conventional B-mode ultrasound that relies on the linear response of tissue to a single transmitted frequency, biharmonic imaging employs a dual-frequency excitation—typically at a fundamental frequency and its harmonic or subharmonic counterpart. This approach enhances the contrast and spatial resolution of images, offering improved tissue characterization and lesion detectability.

Technologically, biharmonic imaging utilizes specialized transducers and sophisticated signal processing algorithms. These systems are designed to generate and receive multiple frequencies simultaneously, capturing both the fundamental and harmonic responses from tissues. The superposition of these responses enables superior discrimination between different tissue types, particularly in complex or heterogeneous anatomical regions. With advances in piezoelectric materials and electronics, modern transducers can now efficiently support the wide bandwidths required for biharmonic excitation and detection.

In 2025, several ultrasound system manufacturers have integrated biharmonic or related multipulse imaging modes into their platforms. Companies such as GE HealthCare and Philips have released clinical ultrasound scanners featuring advanced harmonic imaging capabilities. These systems typically offer selectable modes for tissue harmonic imaging, contrast-enhanced ultrasound, and multipulse techniques—all of which are underpinned by the principles of non-linear acoustics similar to biharmonic imaging. The latest generation systems incorporate real-time processing for biharmonic signals, making the technology viable for routine clinical use in applications such as liver fibrosis assessment, breast lesion characterization, and cardiovascular imaging.

• Improved Diagnostic Confidence: Biharmonic imaging reduces artifacts like speckle and reverberation, resulting in clearer delineation of tissue boundaries and pathology. This is particularly valuable in abdominal and small parts imaging, where subtle differences in tissue elasticity or perfusion are diagnostically relevant.
• Contrast Agent Compatibility: The technique is highly synergistic with microbubble-based ultrasound contrast agents. By selectively detecting the non-linear response of contrast agents at specific harmonic frequencies, biharmonic imaging increases sensitivity for vascular and perfusion studies—a capability being actively developed by manufacturers such as BK Medical, with a focus on interventional and surgical guidance.
• Outlook: Over the next few years, ongoing improvements in transducer materials, miniaturized electronics, and AI-based signal processing are expected to further enhance the performance and accessibility of biharmonic imaging. Industry leaders are investing in research partnerships and clinical trials to validate new indications, including early cancer detection and non-invasive fibrosis staging. As regulatory approvals expand and reimbursement pathways are established, biharmonic imaging is poised to become a routine tool in precision medicine and personalized diagnostics.

Major Players & Innovators: Company Strategies and R&D Initiatives

Biharmonic imaging, an advanced technique in biomedical ultrasound, is rapidly gaining attention due to its capability to enhance image quality and diagnostic accuracy by leveraging higher-order harmonic frequencies. Major ultrasound manufacturers and technology innovators are intensifying their research and development (R&D) efforts to integrate biharmonic and multiparametric imaging modalities into next-generation ultrasound systems.

In 2025, GE HealthCare continues to spearhead innovation in ultrasound technologies, emphasizing harmonic imaging enhancements. Their LOGIQ and Vivid product lines are increasingly incorporating sophisticated signal processing algorithms that support biharmonic and multi-harmonic imaging, aimed at improving tissue characterization and lesion detectability. GE HealthCare’s R&D blueprint for the coming years includes partnerships with academic research centers for real-time implementation of biharmonic image reconstruction, targeting both radiology and cardiology applications.

Philips is also advancing its EPIQ and Affiniti ultrasound systems with a focus on harmonic and multi-frequency imaging. The company’s current strategy involves integrating machine learning algorithms to optimize biharmonic signal extraction, enhancing contrast resolution for abdominal and small parts imaging. Philips has publicly committed to increasing its R&D investment in computational imaging and expects to release new software upgrades in the next two years that will support deeper tissue penetration and reduced noise in biharmonic modalities.

Siemens Healthineers is pursuing a dual-pronged approach: refining its ACUSON line for clinical deployment of biharmonic imaging and collaborating with research institutions to develop prototype transducers optimized for higher-order harmonic generation. In 2025, Siemens is piloting AI-driven image reconstruction pipelines designed to leverage biharmonic datasets for improved visualization of microvascular structures, particularly in oncology and musculoskeletal diagnostics.

Emerging players such as Butterfly Network are exploring portable ultrasound solutions with enhanced harmonic imaging capabilities. Their innovation roadmap includes software-defined platforms that can accommodate biharmonic algorithms via cloud-based updates, democratizing access to advanced imaging in point-of-care settings. Butterfly Network’s collaboration with hospital networks and telemedicine providers is positioned to accelerate the clinical validation and adoption of biharmonic imaging in remote and resource-limited environments.

Across the sector, manufacturers are converging on the development of open APIs and data interfaces to enable third-party researchers to experiment with biharmonic image processing. Over the next few years, this collaborative momentum—coupled with regulatory engagement and continued hardware miniaturization—is expected to drive the clinical translation and global uptake of biharmonic ultrasound imaging.

Current Applications: Biharmonic Imaging in Clinical Ultrasound

Biharmonic imaging is emerging as a significant advancement in biomedical ultrasound, leveraging the superposition of two distinct frequency components to enhance image quality, contrast, and diagnostic efficacy. Currently, in 2025, leading ultrasound equipment manufacturers are integrating biharmonic imaging modalities into their clinical systems, focusing on improved tissue characterization, lesion detectability, and artifact reduction.

In clinical applications, biharmonic imaging is being adopted for abdominal, vascular, and musculoskeletal ultrasound exams. The technique’s unique approach—transmitting and receiving at two separate frequency bands—enables better suppression of noise and reverberation artifacts, which is particularly beneficial for challenging imaging conditions such as in obese patients or those with complex tissue interfaces. For example, Philips Healthcare has incorporated advanced harmonic and biharmonic imaging algorithms into its EPIQ and Affiniti ultrasound platforms, reporting enhanced spatial resolution and tissue differentiation in liver and breast imaging.

Similarly, Siemens Healthineers has implemented multipulse and harmonic imaging technologies within its ACUSON Sequoia and ACUSON Redwood systems. These systems utilize dual-frequency transmission to improve contrast resolution, which is crucial for detecting small lesions and microvascular flow, particularly in oncology and hepatology clinics.

Another area witnessing rapid adoption is cardiovascular ultrasound. Biharmonic imaging is helping clinicians achieve clearer delineation of endocardial borders and better visualization of myocardial structures. GE HealthCare has reported that its LOGIQ and Vivid series ultrasound scanners, equipped with biharmonic and contrast-specific imaging modes, facilitate the assessment of cardiac function and perfusion, even in patients with suboptimal acoustic windows.

Looking ahead, the next few years are expected to see further integration of biharmonic imaging into portable and point-of-care ultrasound (POCUS) systems. Companies such as FUJIFILM Sonosite are actively developing compact platforms that support advanced imaging modes, aiming to make biharmonic and multipulse imaging available in emergency and critical care settings. Moreover, the anticipated rollout of AI-powered image reconstruction—already under development by industry leaders—will likely synergize with biharmonic imaging, offering automated artifact correction and real-time diagnostic decision support.

In summary, biharmonic imaging is transitioning from research and premium systems into routine clinical practice across multiple specialties. With ongoing investments from established ultrasound manufacturers, its adoption is poised to accelerate, promising higher diagnostic confidence and improved patient outcomes through superior image quality and new clinical applications.

Emerging Use Cases: From Oncology to Cardiology

Biharmonic imaging, an advanced modality in biomedical ultrasound, is gaining momentum in clinical applications due to its enhanced contrast resolution and reduced artifact profile. In 2025, its emerging use cases are particularly notable in oncology and cardiology, reflecting both technological maturation and increasing clinical adoption.

In oncology, biharmonic imaging is being leveraged to improve the characterization and delineation of tumors. Its ability to suppress reverberation and side-lobe artifacts enables more precise visualization of tumor margins compared to conventional B-mode ultrasound. For instance, manufacturers such as GE HealthCare have begun integrated research collaborations with major hospitals to explore biharmonic imaging for breast and liver lesion assessment, aiming to provide clinicians with better tools for early detection and treatment planning. Likewise, Siemens Healthineers is piloting biharmonic imaging features in select systems, with early clinical data indicating improved sensitivity for differentiating benign from malignant tissue in dense breast environments.

Cardiology is another area where biharmonic imaging is poised for significant impact. The modality’s superior resolution and contrast facilitate more accurate visualization of myocardial boundaries and valve structures, which is critical for diagnosing and monitoring conditions such as cardiomyopathies and valvular heart disease. In 2025, Philips has announced updates to its EPIQ platform, incorporating biharmonic imaging capabilities to support advanced echocardiography workflows. Preliminary clinical trials at partner medical centers suggest improved detection of subtle myocardial wall motion abnormalities and clearer differentiation between endocardial and epicardial layers.

Beyond these flagship applications, biharmonic imaging is being explored for monitoring treatment response in cancer therapy, with ongoing collaborations between device manufacturers and oncology centers. Additionally, there is growing interest in its use for musculoskeletal ultrasound, where the reduction of imaging artifacts could enhance the assessment of tendon and ligament injuries. Companies such as Canon Medical Systems are actively developing research partnerships to evaluate these novel applications.

Looking ahead, the next few years are expected to see broader regulatory clearances and commercial rollouts of biharmonic imaging features across premium and mid-tier ultrasound systems. The continued collaboration between industry leaders and healthcare providers will likely drive the refinement of clinical protocols, promoting wider adoption in oncology, cardiology, and beyond.

Market Size and Growth Forecasts: 2025–2030

The global market for biharmonic imaging in biomedical ultrasound is anticipated to experience considerable growth between 2025 and 2030, driven by technological advancements, increasing clinical adoption, and expanding applications in diagnostics and therapy. Biharmonic imaging, an advanced nonlinear ultrasound technique, offers enhanced tissue characterization and improved contrast resolution compared to conventional harmonic imaging. This positions it as a valuable tool for early disease detection, tumor characterization, and tissue differentiation.

In 2025, leading ultrasound system manufacturers such as GE HealthCare, Philips, and Siemens Healthineers are actively investing in the refinement and integration of biharmonic imaging algorithms into their premium ultrasound platforms. These developments are aimed at both radiology and point-of-care markets, with a particular emphasis on oncology, hepatology, and cardiovascular imaging. New product launches and software upgrades are expected to accelerate from 2025 onward as regulatory pathways become more clearly defined and clinical evidence supporting biharmonic imaging continues to mount.

The adoption rate is forecast to increase as academic medical centers and large hospital networks in North America, Europe, and Asia-Pacific commence clinical trials and pilot programs exploring the diagnostic value of biharmonic imaging. For instance, Canon Medical Systems and Samsung Medison have announced R&D initiatives focused on next-generation ultrasound imaging, which are likely to incorporate biharmonic techniques over the forecast period.

Market expansion will be supported by rising healthcare expenditure and growing demand for non-invasive diagnostic solutions. Additionally, the trend toward personalized medicine and the need for improved imaging modalities in cancer and liver disease management are expected to further fuel demand. Analysts project that the biharmonic imaging segment could outpace the broader ultrasound market growth rate, with a compound annual growth rate (CAGR) potentially exceeding 10% through 2030, assuming timely regulatory approvals and continued technological innovation from key industry participants. The Asia-Pacific region is projected to demonstrate the fastest adoption curve, attributed to large patient populations and increasing investments in healthcare infrastructure.

Ongoing collaborations between device manufacturers and clinical research institutions are anticipated to generate robust clinical evidence, which will be essential for wider reimbursement and adoption. The coming years are thus set to witness biharmonic imaging transition from a research-focused innovation to a standard feature in advanced ultrasound systems, reinforcing the competitive positioning of companies such as Philips, Siemens Healthineers, and GE HealthCare in the global biomedical imaging market.

Regulatory Pathways & Standards (FDA, IEC, IEEE)

Biharmonic imaging in biomedical ultrasound represents an innovative approach that leverages the transmission and reception of two distinct frequency components to enhance image resolution and tissue characterization. As this technology matures in 2025, regulatory pathways and standards are evolving to ensure safety, efficacy, and interoperability in clinical settings.

In the United States, the U.S. Food and Drug Administration (FDA) continues to oversee the regulatory clearance of ultrasound devices, including those incorporating biharmonic imaging. Devices are generally classified under Class II and require premarket notification (510(k)) submissions, demonstrating substantial equivalence to legally marketed predicate devices. However, the unique signal processing and potential for novel safety profiles associated with biharmonic imaging prompt closer scrutiny regarding acoustic output, thermal index (TI), and mechanical index (MI) parameters. In 2024-2025, the FDA has emphasized the need for comprehensive acoustic output data and validation of image quality metrics specific to biharmonic modalities, particularly when deployed for new clinical applications such as microvascular imaging or elastography.

Globally, the International Electrotechnical Commission (IEC) maintains standards such as IEC 60601-2-37, which addresses the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. Ongoing revisions, anticipated in 2025, are considering the inclusion of evaluation protocols for multiphase and multifrequency imaging, directly relevant to biharmonic techniques. These updates aim to harmonize device labeling requirements, test procedures for acoustic output, and recommendations for reporting non-linear propagation effects, thereby facilitating international market access for manufacturers.

In addition, the Institute of Electrical and Electronics Engineers (IEEE) continues to develop and refine standards related to medical imaging systems. Notably, the IEEE 1859™—Standard for Ultrasound Medical Imaging—provides a framework for measuring system performance, including resolution, contrast, and artifact suppression, all of which are critical for validating biharmonic imaging systems. In 2025, working groups are actively soliciting input from industry stakeholders to address the unique challenges posed by multi-frequency and nonlinear imaging methods.

• Outlook: As biharmonic imaging gains clinical traction, regulatory agencies and standards bodies are expected to further clarify requirements for acoustic safety, image quality assessment, and interoperability. Collaborations between device manufacturers and regulatory authorities, such as those facilitated by the FDA’s Medical Device Innovation Consortium, are likely to accelerate the establishment of consensus guidelines. These efforts will support not only the safe introduction of biharmonic imaging platforms but also broader adoption in precision diagnostics and therapy monitoring in the coming years.

Barriers to Adoption: Technical, Economic, and Clinical Hurdles

Biharmonic imaging, an advanced ultrasound technique leveraging dual-frequency excitation to enhance image contrast and tissue characterization, stands at the cusp of broader clinical integration. However, several barriers—technical, economic, and clinical—continue to challenge its widespread adoption as of 2025 and are likely to persist in the coming years.

Technical Barriers: The implementation of biharmonic imaging demands sophisticated hardware capable of generating and receiving multiple frequency bands simultaneously. Most current clinical ultrasound systems are optimized for single or narrowband harmonic imaging, necessitating significant upgrades or redesigns. The complexity of signal processing algorithms required for biharmonic signal separation and artifact reduction further complicates integration. Leading manufacturers such as GE HealthCare and Philips are actively developing platforms with enhanced processing power and flexible transducer technology, but widespread deployment remains limited as these capabilities are refined and validated in clinical settings.

Economic Hurdles: Transitioning to biharmonic-capable systems involves substantial capital investment. Healthcare providers must weigh the costs of upgrading existing infrastructure, retraining sonographers and clinicians, and maintaining more complex devices. With reimbursement models for advanced ultrasound techniques still evolving, the return on investment is uncertain. Procurement cycles, especially in public healthcare systems, tend to be slow, favoring established technologies with proven cost-effectiveness. This economic inertia slows the introduction of novel modalities like biharmonic imaging into routine clinical use, despite potential long-term savings through improved diagnostic accuracy and reduced need for supplementary imaging.

Clinical Hurdles: Clinically, the added value of biharmonic imaging over established harmonic and conventional ultrasound remains under investigation. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) require robust evidence of safety and efficacy before approving new diagnostic modalities. Ongoing multicenter studies are evaluating the clinical benefits of biharmonic imaging in liver fibrosis staging, tumor delineation, and vascular imaging, but results have yet to reach the critical mass needed to drive guideline changes or widespread clinical adoption. Furthermore, there is a need for consensus on standardized protocols and interpretation criteria, which industry leaders and professional societies are currently working to establish.

Looking ahead to the next few years, overcoming these barriers will depend on continued collaboration between manufacturers, regulatory agencies, and clinical researchers. As technical challenges are addressed and clinical evidence accumulates, economic incentives may align more clearly, paving the way for biharmonic imaging to move from research and pilot programs into routine clinical practice.

Investment & Partnership Trends: Venture Capital and Alliances

Biharmonic imaging, an advanced modality in biomedical ultrasound, is gaining considerable attention from venture capitalists and industry leaders as its clinical potential becomes more widely recognized. This interest is fueled by the technology’s promise to improve tissue characterization, increase image resolution, and facilitate early disease detection—critical priorities in modern healthcare. As of 2025, the investment landscape is witnessing significant activity centered on collaborative ventures and capital infusions designed to accelerate the translation of biharmonic imaging from research to clinical markets.

Leading ultrasound manufacturers are expanding their R&D budgets and forming partnerships with academic institutions and innovative startups to explore biharmonic and other multipulse imaging techniques. For example, Philips and GE HealthCare have both publicly committed to investing in next-generation ultrasound platforms, with a focus on enhancing image quality and diagnostic confidence through novel pulse sequences, including biharmonic approaches. These companies are actively seeking alliances with university medical centers and research consortia to co-develop prototypes, share intellectual property, and streamline regulatory pathways.

Venture capital activity in 2025 is characterized by early- and growth-stage investments targeting startups that specialize in advanced ultrasound signal processing and machine learning integration. Notably, Siemens Healthineers has expanded its corporate venture arm to scout and fund emerging companies developing biharmonic imaging algorithms and hardware modules compatible with existing ultrasound systems. Similarly, Canon Medical Systems Corporation is investing in strategic collaborations to incorporate biharmonic imaging into point-of-care and portable ultrasound devices, viewing this as a path to market differentiation.

Industry alliances are also forming on a global scale. In 2024 and early 2025, several consortia such as the European Society of Radiology’s Ultrasound Working Group have initiated multi-center pilot projects involving industrial partners and clinical sites to validate the safety and utility of biharmonic imaging in diverse patient populations (European Society of Radiology). These partnerships facilitate data sharing, benchmarking, and standardization—key prerequisites for broader commercial adoption.

Looking ahead, the next few years are expected to see a rise in cross-sector investments and licensing deals as biharmonic imaging technologies mature and approach regulatory approval. Industry leaders are likely to deepen their commitment to open innovation, seeking out academic spin-offs and agile startups that can accelerate the commercialization timeline. This dynamic investment and partnership environment underscores a growing consensus within the medical imaging community: biharmonic imaging holds transformative potential, and strategic collaboration will be essential to realize its clinical and commercial value.

Future Outlook: Next 3–5 Years of Disruptive Innovation and Adoption

Biharmonic imaging, a nonlinear ultrasound modality utilizing simultaneous transmission or processing of two distinct frequencies, is poised to transform biomedical ultrasound over the next 3–5 years. This technique offers improved contrast, enhanced resolution, and superior artifact suppression compared to traditional harmonic and fundamental imaging, making it highly promising for both diagnostic and interventional applications.

As of 2025, leading ultrasound system manufacturers are actively investing in advanced signal processing and transducer technologies to support biharmonic imaging. For example, GE HealthCare and Philips have expanded their research and development in nonlinear imaging modes, with product pipelines increasingly referencing multi-frequency and composite imaging capabilities. Emerging systems are expected to leverage custom transducer arrays and real-time digital beamforming to optimize the generation and detection of biharmonic signals.

In the near term, biharmonic imaging is anticipated to see its fastest adoption in areas where improved tissue differentiation and lesion characterization are critical. Breast, liver, and vascular imaging are notable targets, as early clinical trials—often in collaboration with academic medical centers—demonstrate clearer delineation of tumor margins and better visualization of microvasculature than conventional B-mode or single-frequency harmonic imaging. Siemens Healthineers and Canon Medical Systems are among the companies collaborating with clinical partners to evaluate biharmonic prototypes for these indications.

Regulatory momentum is also expected to accelerate, as improved diagnostic accuracy aligns with healthcare priorities for early disease detection. Companies are preparing documentation and safety data for regulatory submissions in major markets, with initial clearances anticipated by 2027. The increased availability of FDA-cleared nonlinear imaging platforms will further legitimize and spur commercial adoption.

Over the next half-decade, disruptive innovation is likely in three main areas:

• AI Integration: Integration of artificial intelligence and machine learning algorithms with biharmonic imaging data is expected, facilitating automated tissue classification and quantification. Companies such as Samsung Medison are already advancing AI-powered ultrasound analytics, which will synergize with the richer datasets provided by biharmonic techniques.
• Point-of-Care Expansion: Miniaturization and increased computational power will bring biharmonic capabilities to handheld and portable ultrasound devices. This trend aligns with the growing adoption of point-of-care ultrasound, as seen in the recent product strategies of Butterfly Network, Inc..
• Theranostic Applications: Biharmonic imaging may play a role in guiding and monitoring ultrasound-mediated therapies, including drug delivery and ablation, as research expands in collaboration with device manufacturers and therapeutic ultrasound consortia such as the Focused Ultrasound Foundation.

By 2030, biharmonic imaging is expected to become a standard option in advanced ultrasound platforms, driving a new wave of precision diagnostics and image-guided therapy in multiple clinical specialties.

Sources & References

• GE HealthCare
• Siemens Healthineers
• Philips Healthcare
• Butterfly Network
• Canon Medical Systems
• Institute of Electrical and Electronics Engineers (IEEE)
• European Society of Radiology
• Focused Ultrasound Foundation