Table of Contents
- Executive Summary: Key 2025 Trends in Quasistatic Ultrasound QA
- Market Size & Growth Forecast (2025–2030)
- Core Technologies: Current Capabilities and Innovations
- Leading Players & Official Industry Associations
- Adoption Drivers: Regulatory, Clinical, and Economic Factors
- Competitive Landscape: Supplier Strategies and Differentiators
- Emerging Applications: Beyond Traditional Ultrasound QA
- Standards, Compliance, and QA Protocol Updates (2025)
- Challenges and Barriers to Widespread Adoption
- Future Outlook: Disruptive Trends & Strategic Recommendations
- Sources & References
Executive Summary: Key 2025 Trends in Quasistatic Ultrasound QA
Quasistatic ultrasound quality assurance (QA) systems are emerging as pivotal components in the routine maintenance and verification of diagnostic and therapeutic ultrasound equipment. In 2025, the sector is experiencing notable advancements, primarily driven by the integration of automation, digital data management, and increased regulatory scrutiny. These changes are shaping the deployment, adoption, and innovation of QA products across hospitals, imaging centers, and research institutions.
A major trend is the shift toward automated and semi-automated QA platforms. Manufacturers such as Computerized Imaging Reference Systems, Inc. (CIRS) and Gammex (A Sun Nuclear Company) are expanding their portfolios to include phantoms and software solutions that simplify measurement processes and reduce operator variability. For example, CIRS’s ultrasound QA phantoms are increasingly paired with digital tracking and reporting tools, addressing the industry’s need for standardized data capture and streamlined workflow integration.
Cloud-based data management is also gaining momentum. Companies like Sun Nuclear Corporation are piloting web-enabled QA management platforms, allowing for multi-site data aggregation, remote access, and compliance monitoring. This trend supports growing requirements for traceability and documentation, especially as regulatory agencies emphasize the importance of longitudinal QA records for accreditation and patient safety.
In terms of international standards and protocols, organizations such as the American Association of Physicists in Medicine (AAPM) and the European Association of Nuclear Medicine (EANM) are actively updating guidelines for ultrasound QA, with an emphasis on repeatability, reproducibility, and digital documentation. The alignment of commercial QA systems with these evolving protocols is prompting vendors to enhance the interoperability of their solutions and offer regular software updates.
Looking ahead, the next few years are expected to bring further integration of artificial intelligence (AI) into QA systems. Early-stage developments from EchoNous and other innovators point toward automated image analysis and anomaly detection, which may further reduce manual QA workload and help standardize quality assessments across diverse clinical environments.
In summary, 2025 marks a period of rapid evolution for quasistatic ultrasound QA systems, characterized by automation, digitalization, and regulatory alignment. These trends are set to continue, improving the reliability, efficiency, and traceability of ultrasound quality assurance in clinical practice.
Market Size & Growth Forecast (2025–2030)
The global market for quasistatic ultrasound quality assurance (QA) systems is poised for steady growth between 2025 and 2030 as applications in clinical diagnostics, research, and device manufacturing continue to expand. Quasistatic ultrasound QA systems are integral for verifying the performance and calibration of ultrasound equipment, particularly in elasticity imaging, which is increasingly used for tissue characterization in oncology, hepatology, and musculoskeletal assessments.
Major manufacturers such as CIRS Inc. and Gammex (a Sun Nuclear company) are at the forefront of QA phantom and system development, offering products that support routine performance checks and accreditation compliance. The growing demand for high-precision imaging in both emerging and established healthcare markets is driving investment in advanced QA tools, including those enabling quasistatic testing.
Market expansion is further supported by regulatory requirements: organizations like the American Association of Physicists in Medicine (AAPM) and the International Electrotechnical Commission (IEC) specify QA protocols that include quasistatic methods for elasticity imaging systems. These standards are prompting hospitals, imaging centers, and device manufacturers to adopt more rigorous and regular QA programs.
By 2025, North America and Europe will represent the largest regional markets, due to established ultrasound infrastructure and stringent quality standards. However, Asia-Pacific is anticipated to exhibit the fastest growth through 2030, fueled by healthcare modernization and increased adoption of advanced imaging modalities in countries like China, India, and South Korea.
- Technological Innovations: Companies such as CIRS Inc. are introducing new phantom materials and designs to enhance the accuracy and repeatability of quasistatic measurements, addressing user demand for robust and user-friendly QA solutions.
- Integration with Digital Workflows: QA systems are increasingly being designed for compatibility with digital archiving and reporting platforms, streamlining compliance and traceability.
Looking ahead, the quasistatic ultrasound QA systems market is projected to achieve a compound annual growth rate in the mid- to high-single digits between 2025 and 2030, with revenues driven by replacement cycles, emerging clinical applications, and ongoing updates to international QA protocols. Increased focus on precision medicine and device accreditation will continue to stimulate demand for advanced QA solutions in both mature and developing markets.
Core Technologies: Current Capabilities and Innovations
Quasistatic ultrasound quality assurance (QA) systems play a vital role in verifying and maintaining the accuracy, consistency, and safety of diagnostic and therapeutic ultrasound devices. In 2025, the field is characterized by rapid technological advancements, automation, and integration with digital health infrastructure, reflecting industry-wide priorities on precision, efficiency, and regulatory compliance.
At the core of these systems are phantoms—test objects mimicking tissue properties—and specialized software platforms for performance evaluation. Leading manufacturers such as CIRS Inc. and Gammex (Sun Nuclear Corporation) have continued to innovate in this arena. Recent device generations feature advanced, tissue-equivalent materials that are more durable and stable under repeated testing, ensuring more reliable long-term QA. These phantoms support both basic and advanced tests, such as depth of penetration, axial and lateral resolution, contrast detail, and grayscale linearity, aligning with international standards.
Automation is a prominent trend, with QA systems increasingly equipped with machine vision and software-driven analysis. For instance, eZono AG has developed platforms that integrate image capture with automated measurement algorithms, reducing operator variability and streamlining QA workflows. Similarly, 3D Systems offers simulators and QA solutions with cloud connectivity, enabling centralized tracking and auditing of ultrasound system performance across multiple locations.
Digital integration is further supported by connectivity features, allowing seamless reporting, traceability, and compliance with regulatory frameworks such as those established by the American College of Radiology (ACR) and the European Federation of Organizations for Medical Physics (EFOMP). This ensures QA data is readily accessible for accreditation, audit, and remote expert review. Recent software updates by CIRS Inc. and Gammex have focused on user interface improvements and compatibility with hospital IT systems, facilitating easier data exchange and documentation.
Looking toward the next few years, manufacturers are expected to further enhance the fidelity of phantoms, introduce artificial intelligence-driven analytics, and deepen integration with broader quality management systems. There is also a growing emphasis on QA for point-of-care and portable ultrasound devices, as usage expands beyond traditional radiology departments. As regulatory requirements evolve and clinical reliance on ultrasound grows, the demand for robust, automated, and interoperable QA systems will likely accelerate, driving continued innovation and collaboration between device makers, healthcare providers, and standards organizations.
Leading Players & Official Industry Associations
The landscape of quasistatic ultrasound quality assurance (QA) systems in 2025 is defined by a select group of leading manufacturers and influential industry associations that shape standards, foster innovation, and support clinical adoption. These entities focus on ensuring that ultrasound elastography and related modalities deliver reliable, reproducible, and safe performance—a necessity as ultrasound technologies become more integral to diagnostic workflows.
Among the foremost commercial players, CIRS Inc. stands out for its advanced ultrasound QA phantoms, including models specifically designed for elastography and strain imaging calibration. Their products are widely used in hospitals and research institutions, enabling routine performance checks and compliance with regulatory requirements. Gammex (now part of Sun Nuclear) also maintains a strong presence, offering comprehensive QA solutions including phantoms and software tools for verifying quasistatic ultrasound system accuracy and consistency.
European innovation is represented by companies such as Gammasonics, which provides a portfolio of QA devices tailored for both static and dynamic ultrasound modalities. Similarly, Kyoto Kagaku Co., Ltd. from Japan delivers a spectrum of QA phantoms, including those for elastography, and is recognized for their high-fidelity tissue-mimicking materials.
On the industry association front, the American Institute of Ultrasound in Medicine (AIUM) plays a pivotal role in issuing practice parameters and QA guidelines for elastography and related ultrasound techniques. These recommendations, coupled with ongoing educational activities, influence both clinical and technical standards. The European Federation of Societies for Ultrasound in Medicine and Biology (EFSUMB) is similarly active, particularly in harmonizing QA protocols and supporting multi-center research efforts across Europe. In addition, the International Electrotechnical Commission (IEC) continues to update relevant standards (such as IEC 60601-2-37) governing the safety and performance of diagnostic ultrasound equipment, including provisions for elastography system QA.
Looking forward to 2025 and beyond, sector leaders are expected to focus on automation, AI-driven image analysis, and remote QA capabilities. The push for standardized, reproducible QA workflows—facilitated by both manufacturers and associations—will likely accelerate as clinical demands grow and regulatory scrutiny intensifies. These collaborative efforts underscore the sector’s commitment to safe, high-quality ultrasound elastography and the ongoing evolution of best practices.
Adoption Drivers: Regulatory, Clinical, and Economic Factors
The adoption of quasistatic ultrasound quality assurance (QA) systems is shaped by a confluence of regulatory, clinical, and economic factors, with 2025 set to be a pivotal year for their integration into routine ultrasound practice. Regulatory standards, particularly in regions with highly developed healthcare frameworks, are increasingly emphasizing the need for robust QA protocols. In the United States, the U.S. Food and Drug Administration (FDA) underscores the importance of quality assurance in diagnostic ultrasound through its standards and guidance for medical devices. Similarly, European requirements under the Medical Device Regulation (MDR 2017/745) are driving hospitals and clinics to formalize periodic QA processes, including those using quasistatic systems.
Clinically, the push toward higher accuracy in diagnostic imaging is a major adoption driver. Quasistatic ultrasound QA systems are valued for their ability to detect subtle degradations in probe performance, such as changes in elasticity imaging, which are not easily identified during routine clinical use. This is particularly relevant for applications in breast, liver, and musculoskeletal imaging, where elastography is increasingly used for diagnosis and treatment planning. Institutions such as the International Atomic Energy Agency (IAEA) and professional societies including the American Institute of Ultrasound in Medicine (AIUM) have issued guidelines recommending regular QA checks, which is further catalyzing investment in dedicated QA systems.
On the economic front, cost containment and equipment longevity are significant factors. Healthcare providers are recognizing that proactive QA, including the use of quasistatic systems, can minimize costly equipment downtime and extend the lifespan of ultrasound probes and systems. Vendors such as CIRS Inc. and Gammex (an affiliate of Sun Nuclear Corporation) provide specialized QA phantoms and software platforms that automate and document probe performance, reducing manual workload and error rates.
Looking ahead to 2026 and beyond, the outlook for quasistatic ultrasound QA systems is strongly positive. The convergence of more stringent regulatory oversight, expanding clinical applications—especially in elastography and point-of-care ultrasound—and the availability of increasingly user-friendly, automated QA solutions will likely accelerate adoption. Industry leaders and standards organizations are expected to further refine and harmonize QA recommendations, reinforcing the necessity of such systems in ensuring diagnostic accuracy and patient safety.
Competitive Landscape: Supplier Strategies and Differentiators
The competitive landscape for quasistatic ultrasound quality assurance (QA) systems in 2025 is shaped by a combination of technological innovation, regulatory compliance, and increasing demand for standardized imaging performance in clinical and research environments. Key suppliers are differentiating their offerings through integrated software solutions, automation, and compatibility with diverse ultrasound platforms.
Major players such as Computerized Imaging Reference Systems, Inc. (CIRS) and Gammex, Inc. (a Sun Nuclear Corporation company) maintain strong positions through comprehensive phantom portfolios and user-oriented QA software. Both companies emphasize traceable calibration, reproducibility of results, and support for automated data capture, which is increasingly demanded by hospital networks and independent diagnostic centers seeking to streamline QA workflows.
In 2025, CIRS continues to innovate with modular phantom designs that allow users to tailor QA procedures to specific clinical requirements, as well as offering cloud-based data management for multi-site organizations. Sun Nuclear Corporation is focusing on integration with hospital information systems and expanding its software analytics to include machine learning–based anomaly detection, aiming to reduce false positives and speed up QA review cycles.
Emerging competitors such as The Phantom Laboratory are targeting niche segments with customizable solutions for research and advanced therapy applications, leveraging rapid prototyping and user-driven design. Additionally, Kyoto Kagaku Co., Ltd. is strengthening its global distribution network and investing in educational support, recognizing the need for robust training as ultrasound QA adoption widens in developing markets.
Differentiation strategies across the sector include:
- Interoperability: Ensuring phantoms and software are compatible with a broad range of ultrasound equipment from manufacturers such as GE HealthCare and Siemens Healthineers.
- Automation: Streamlining test protocols to minimize operator dependency and reduce measurement variability.
- Data Management: Developing secure, cloud-enabled solutions for tracking QA metrics, facilitating regulatory compliance, and supporting remote audits.
- Customization: Offering modular or application-specific phantoms to cater to evolving clinical and research needs.
Looking ahead, the market is expected to see further convergence between QA systems and imaging informatics, with suppliers racing to embed artificial intelligence and predictive analytics. The emphasis on standardized, auditable QA processes—driven by national and international guidelines—will continue to shape supplier strategies, especially as ultrasound expands into new modalities and point-of-care environments.
Emerging Applications: Beyond Traditional Ultrasound QA
Quasistatic ultrasound quality assurance (QA) systems are gaining attention for their potential to extend beyond conventional image quality and calibration checks, opening new avenues in clinical and research applications. Traditionally, QA in ultrasound has relied on phantoms and measurement tools to assess parameters such as spatial resolution, contrast, and uniformity. However, quasistatic systems leverage controlled mechanical loading and advanced elastography techniques to evaluate not only the performance of the ultrasound device but also the consistency of tissue-mimicking materials and system responses under various stress conditions.
In 2025, the integration of quasistatic methods is being explored in several emerging settings. For example, leading manufacturers like Computerized Imaging Reference Systems, Inc. (CIRS) and Gammex (a Sun Nuclear company) have begun incorporating elastography-compatible phantoms and software into their QA product lines. These systems support both routine performance checks and advanced research, such as validating strain imaging algorithms and calibrating systems for quantitative tissue stiffness mapping. CIRS, in particular, has introduced phantoms designed for both static and dynamic elastography QA, reflecting a growing trend towards multimodal testing environments.
Healthcare providers and research institutions are now piloting quasistatic QA protocols for applications beyond diagnostic imaging. For instance, quasistatic systems are being used to verify the accuracy and reproducibility of strain and shear-wave elastography measurements in liver fibrosis assessment and musculoskeletal imaging. This is critical as regulatory agencies and clinical guidelines increasingly emphasize the need for quantitative imaging biomarkers and standardized QA protocols. The American Institute of Ultrasound in Medicine (AIUM) continues to update their recommendations, emphasizing the importance of QA tools that can validate emerging elastographic techniques.
- In academic medical centers, there is a growing interest in using quasistatic QA systems to support multi-center clinical trials, ensuring inter-site consistency in quantitative elastography metrics.
- Manufacturers such as Sun Nuclear are expanding their portfolios with software modules that automate the acquisition and analysis of quasistatic elastography data, reducing user variability and improving traceability.
- There is an outlook for regulatory recognition of quasistatic QA protocols as part of device premarket submissions, particularly as advanced ultrasound elastography techniques move towards widespread clinical adoption.
Looking ahead to the next few years, the role of quasistatic ultrasound QA systems is expected to expand, with greater emphasis on automation, integration with hospital QA workflows, and support for new clinical applications such as oncology and therapeutic ultrasound. This evolution reflects a broader industry shift towards precision imaging and standardized quality assurance across the ultrasound ecosystem.
Standards, Compliance, and QA Protocol Updates (2025)
The year 2025 marks a pivotal period for standards development, compliance requirements, and protocol updates in the domain of quasistatic ultrasound quality assurance (QA) systems. Quasistatic ultrasound, widely used for elastography and tissue characterization, requires stringent QA processes to ensure accurate, reproducible diagnostics across clinical settings. Recent years have seen growing attention from industry bodies and manufacturers to standardize and advance QA protocols, addressing both technological advances and regulatory expectations.
In 2025, there is a concerted push from organizations such as the American Association of Physicists in Medicine (AAPM) and the American Institute of Ultrasound in Medicine (AIUM) to harmonize QA protocols for quasistatic ultrasound systems. The AAPM’s Ultrasound Subcommittee continues to refine its guidelines for performance evaluation, emphasizing routine testing of strain imaging accuracy, system linearity, and reproducibility. These recommendations form the basis for updates in accreditation programs, with a focus on automated and semi-automated phantom-based testing methods.
Manufacturers are responding by integrating enhanced QA tools and automated test routines into their latest platforms. For example, GE HealthCare and Siemens Healthineers have both introduced software modules that facilitate regular elastography system QA, including automated strain measurement validation and system drift monitoring. These features support compliance with evolving standards and reduce the burden of manual QA, helping clinical teams adhere to best practices with minimal workflow disruption.
Phantom suppliers such as CIRS, Inc. and Gammex (a division of Sun Nuclear) have updated their product lines to include advanced tissue-mimicking phantoms specifically designed for quasistatic elastography. These phantoms enable quantitative assessment of strain and elasticity, supporting the more rigorous and nuanced QA protocols now recommended for clinical practice.
Looking ahead, the next few years are expected to bring further harmonization of QA standards internationally, with ongoing collaboration between North American and European bodies. There is also an emerging emphasis on digital traceability and cloud-based QA recordkeeping, with companies like echOpen and major OEMs exploring integration of QA data management platforms. These developments are anticipated to improve transparency, support remote audits, and facilitate faster adoption of updated protocols.
In summary, 2025 is characterized by both incremental and transformative changes in standards and compliance for quasistatic ultrasound QA. The integration of automation, advanced phantoms, and digital record-keeping reflects a broader industry commitment to diagnostic reliability and regulatory alignment, setting the stage for sustained innovation and improved patient care.
Challenges and Barriers to Widespread Adoption
Quasistatic ultrasound quality assurance (QA) systems have emerged as vital tools in ensuring the reliability and performance of elastography and tissue stiffness imaging. Despite their technical advances, several challenges continue to impede widespread adoption as of 2025, with implications for the pace of uptake in the coming years.
A primary barrier is the lack of standardization in both protocols and performance metrics. Currently, institutions and manufacturers often rely on proprietary procedures for QA, impairing interoperability and benchmarking across different platforms. For example, leading manufacturers like Siemens Healthineers and GE HealthCare have developed internal QA processes for their elastography systems, but these are not universally harmonized. The absence of consensus guidelines from industry bodies such as the American Institute of Ultrasound in Medicine further complicates the establishment of routine, standardized QA workflows.
Cost and resource allocation represent another significant hurdle. Advanced QA systems, such as those developed by CIRS Inc. and Gammex, require upfront investment in phantoms and software, as well as ongoing staff training. Many smaller clinics and resource-limited hospitals may deprioritize QA due to budgetary constraints or lack of immediate return on investment, thus hindering universal implementation.
Technical complexity and workflow disruption also present adoption barriers. Integrating quasistatic QA protocols can be time-consuming and may interfere with clinical throughput, especially in high-volume imaging centers. The need for manual setup, calibration, and result interpretation is cited by users as a deterrent to routine use, per feedback collected by manufacturers such as CIRS Inc..
Another challenge is the limited regulatory and reimbursement support for QA activities in ultrasound elastography. While regulatory agencies such as the U.S. Food & Drug Administration emphasize device safety and performance, they do not mandate routine QA for elastography, leaving compliance largely voluntary. This lack of formal requirement slows institutional investment in QA systems.
Looking ahead, addressing these barriers will require coordinated efforts between manufacturers, clinical organizations, and standard-setting bodies. Initiatives aiming to develop international standards for QA in elastography, as discussed within the IEEE and other technical consortia, may gradually improve interoperability and acceptance. However, until such standardization and regulatory alignment are achieved, and costs reduced, the adoption of quasistatic ultrasound QA systems is expected to remain fragmented through the next few years.
Future Outlook: Disruptive Trends & Strategic Recommendations
Quasistatic ultrasound quality assurance (QA) systems are poised for significant transformation in 2025 and the coming years, driven by technological innovation, regulatory evolution, and the increasing demand for precise diagnostic imaging. As healthcare providers and device manufacturers strive for higher standards in patient safety and imaging reliability, several disruptive trends are set to shape the landscape.
One prominent trend is the integration of artificial intelligence (AI) and machine learning for automated QA processes. Companies such as EchoFlow and CIRS Inc. are actively developing AI-powered solutions that can rapidly analyze ultrasound data, reducing manual intervention and minimizing human error. These platforms are expected to provide real-time feedback on system performance, supporting a shift toward predictive maintenance and continuous QA, rather than periodic manual checks.
Another pivotal development is the standardization of QA protocols. Industry bodies like the American Association of Physicists in Medicine (AAPM) are publishing updated guidelines that encourage uniformity and repeatability in ultrasound QA practices. Adherence to such standards is becoming essential, particularly as global regulatory agencies tighten requirements for device calibration and performance verification.
The role of connectivity and data management is also increasing. Manufacturers such as Gammex (a Sun Nuclear company) are introducing cloud-enabled QA devices, allowing for centralized tracking of equipment status across multiple sites. This facilitates benchmarking, compliance auditing, and proactive identification of equipment degradation, which is crucial for large hospital networks and imaging centers.
Looking ahead, miniaturization and portability will further disrupt conventional QA workflows. Compact, wireless QA phantoms and sensors are being prototyped by companies like ImSimQA, enabling point-of-care verification and expanding QA to settings beyond traditional imaging departments. Such advancements are expected to support the broader adoption of ultrasound in ambulatory and remote care environments.
Strategically, stakeholders are advised to invest in interoperable QA systems that can evolve alongside imaging equipment and IT infrastructure. Collaborating with vendors that prioritize compliance with international standards and offer scalable, AI-enhanced platforms will position healthcare providers to meet upcoming regulatory, operational, and clinical demands.
In summary, the future outlook for quasistatic ultrasound QA systems is marked by automation, standardization, connectivity, and portability. Industry leaders embracing these trends will be well-positioned to deliver higher quality imaging, improve patient safety, and optimize operational efficiency as the sector advances through 2025 and beyond.
Sources & References
- Computerized Imaging Reference Systems, Inc. (CIRS)
- Gammex (A Sun Nuclear Company)
- Sun Nuclear Corporation
- American Association of Physicists in Medicine (AAPM)
- European Association of Nuclear Medicine (EANM)
- EchoNous
- eZono AG
- 3D Systems
- Gammasonics
- Kyoto Kagaku Co., Ltd.
- American Institute of Ultrasound in Medicine (AIUM)
- International Atomic Energy Agency (IAEA)
- GE HealthCare
- Siemens Healthineers
- IEEE
