Connect with us

Technology

Tumor Ablation Market Set to Surge to US$ 1.8 Billion by 2031, Growing at 11.6% CAGR: Wissen Research

Published

on

SHERIDAN, Wyo., Oct. 19, 2026 /PRNewswire/ — The global tumor ablation market is valued at USD 1.04 billion in 2026 and is projected to reach USD 1.8 billion by 2031, growing at a CAGR of 11.6% over the forecast period (2026–2031), according to a new study by Wissen Research.

Tumor ablation destroys targeted tumor tissue with heat, cold, or other forms of energy while trying to spare the healthy tissue around it. In percutaneous procedures, a physician threads a probe through the skin and into the tumor under imaging guidance, which lowers the risks that come with standard surgery. For patients who are not candidates for surgery, or for whom preserving organ function matters, it is an increasingly important option.

The demand starts with patient numbers. The International Agency for Research on Cancer (IARC) counted about 20 million new cancer cases and 9.7 million cancer deaths worldwide in 2022, and expects the figure to rise significantly by 2050. A growing population of patients with solid tumors is driving demand for localized treatments that can work alongside surgery, radiation, and systemic therapy or, in specific cases, replace them.

Download Free Sample PDF — Explore Key Market Trends, CAGR & Patent Highlights: https://www.wissenresearch.com/request-a-sample/?report=tumor-ablation-market 

The Probe Is Only Part of the System: Imaging and Planning Software Now Sit Beside the Energy Source

Tumor ablation is moving away from standalone energy delivery devices toward integrated systems. Modern platforms increasingly combine the energy source with CT, ultrasound, MRI, navigation, temperature sensors, and treatment planning software, so the physician can place the probe precisely, watch the treated zone, and plan how far the treatment should extend. CT and ultrasound help position the probe, MRI gives detailed images of the treated area, and software lets the physician define tumor borders before treatment begins. The report describes an industry that is becoming more technology- and software-oriented, with competition shifting toward more efficient image-guided tumor ablation, tighter control of the procedure, and larger, more predictable ablation zones.

Precision matters because physics can work against the treatment. The National Cancer Institute (NCI) notes that radiofrequency ablation, microwave ablation, and cryoablation are used for localized liver cancer, but tumor size and location can limit how well thermal ablation works. When a tumor sits close to a large blood vessel, flowing blood can carry heat away from the treatment area, a heat-sink effect that reduces effectiveness.

Beyond Heat: Freezing, Focused Ultrasound, and Electrical Pulses Widen the Toolkit

Radiofrequency ablation remained a leading technology in 2025 on the strength of its long clinical track record and wide availability, and the NCI lists it among the local treatment options for liver malignancies. Microwave ablation is gradually gaining ground because it can offer higher temperatures, larger ablation areas, and simultaneous treatment through multiple devices, while cryoablation, which destroys tissue by freezing and thawing, is getting stronger in kidney and prostate cancer.

Other approaches are broadening what can be treated. Irreversible electroporation (IRE) uses short electrical pulses instead of heat to disrupt cells, and is being explored where conventional heating is difficult, such as near sensitive structures. High-intensity focused ultrasound (HIFU) delivers energy through concentrated ultrasound signals. Both remain more specialized than the established thermal methods, and the report notes that the state of the technology and the available evidence vary from one application to another, even as ablation spreads beyond the liver and kidney to other solid tumors.

Talk to an Industry Analyst — Request Custom Country Segmentation & Technology Deep-Dives: https://www.wissenresearch.com/request-customization/?report=tumor-ablation-market 

What’s Fueling Growth in the Tumor Ablation Market

A larger cancer patient population: More patients with solid tumors are creating demand for localized treatments alongside surgery, radiotherapy, and systemic therapy.Preference for minimally invasive procedures: Ablation can be performed through the skin, which makes it an option when surgery is not possible or when treatment must avoid harming surrounding healthy tissue.Wider use of image-guided techniques: CT, ultrasound, and MRI allow precise probe placement, treatment planning, and monitoring of the ablation zone.Better ablation equipment: Improvements in microwave equipment and electrodes, cryoprobes, HIFU systems, and electroporation technology give physicians finer control over tumor destruction.More tumor types in play: Ablation is being applied or researched in liver, kidney, lung, prostate, breast, bone, and other localized tumors.Demand for organ-sparing treatment: Destroying a localized tumor requires less extensive intervention and preserves nearby healthy tissue.

Challenges Facing the Tumor Ablation Market

The central challenge is destroying the whole tumor while protecting what is next to it. Results depend on the tumor’s size, shape, location, and tissue properties, and on how close it sits to vital structures. Tumors that are not fully destroyed can survive at the treatment margin, raising the risk of local recurrence and the need for repeat procedures or additional treatment. Tumors near bile ducts, airways, nerves, and intestines can force physicians to reduce the energy they deliver, and inconsistent probe placement can leave tumor tissue behind. That is why imaging, probe positioning, treatment planning, and monitoring have to be clear and dependable.

Adoption has its own hurdles. Using advanced imaging technology involves regulatory requirements, the availability of clinical evidence, and the level of physician training, and technologies such as irreversible electroporation, HIFU, and laser ablation are still developing.

Recent Strategic Developments in the Tumor Ablation Market

In August 2026, IceCure Medical Ltd. of Israel entered into an exclusive distribution agreement with Scovas Medical for its ProSense cryoablation systems in the Netherlands. The agreement expanded ProSense commercialization for breast cancer and interventional oncology, while the Netherlands-based THERMAC trial advanced to Phase III, supporting further clinical adoption of cryoablation.

In May 2026, AngioDynamics, Inc. of the United States announced that Palmetto GBA had issued a final Medicare coverage determination for irreversible electroporation using the NanoKnife System for selected prostate cancer cases and metastatic colorectal cancer to the liver. The coverage took effect July 5, 2026, supporting broader reimbursement and patient access to non-thermal tumor ablation.

One development opens a new market for cryoablation, and the other makes a non-thermal technique easier for patients to access.

Key Insights from Tumor Ablation Market Analysis

Radiofrequency ablation held a leading position by technology type in 2025, supported by extensive clinical experience, wide availability, and its use in liver, kidney, and lung tumors.Systems held a leading position by product type in 2025, reflecting rising uptake of energy-based solutions for minimally invasive tumor treatment. The segment spans radiofrequency, microwave, cryoablation, and irreversible electroporation systems, and manufacturers are focusing on energy delivery, control of the treatment zone, probe and electrode configuration, cooling, monitoring, and compatibility with image guidance.North America held the largest regional share in 2025, supported by established healthcare infrastructure, strong interventional radiology capabilities, high acceptance of minimally invasive oncology treatment, and well-known device makers. The United States accounts for most of the region’s market, with many cancer treatment centers, skilled specialists, clinical research infrastructure, and strict medical-device regulation.Asia Pacific is the fastest-growing region, driven by a growing number of cancer patients and rapid healthcare development, with China, Japan, South Korea, and India adopting interventional oncology and image-based treatment techniques.The market is moderately consolidated, with established medical-device companies competing alongside specialized ablation technology manufacturers.

Key Players in the Tumor Ablation Market

Leading companies in the tumor ablation market are focusing on radiofrequency and microwave energy delivery, cryoablation, HIFU, irreversible electroporation, image-guided intervention, navigation, treatment planning, and expansion into additional solid-tumor applications.

The report names Medtronic plc (Ireland), Boston Scientific Corporation (US), Johnson & Johnson (US), AngioDynamics, Inc. (US), and IceCure Medical Ltd. (Israel) as the top five players, with established positions across radiofrequency ablation, microwave ablation, cryoablation, and other interventional oncology technologies. Competition turns on energy-delivery performance, treatment precision, probe design, the predictability of the ablation zone, clinical evidence, regulatory approvals, imaging integration, procedural efficiency, and physician adoption.

Other companies profiled in the report include Stryker Corporation (US), Bioventus Inc. (US), CONMED Corporation (US), Merit Medical Systems, Inc. (US), Siemens Healthineers AG (Germany), and Olympus Corporation (Japan). The report also covers Terumo Corporation, EDAP TMS S.A., Insightec Ltd., Theraclion SA, Chongqing Haifu Medical Technology Co., Ltd., Alpinion Medical Systems Co., Ltd., STARmed Co., Ltd., SonaCare Medical, LLC, HealthTronics, Inc., and Novian Health, Inc., among others.

Regional Analysis and Growth Opportunities

North America leads the tumor ablation market, supported by advanced healthcare infrastructure, growing interventional radiology capacity, high spending on cancer treatment, wide adoption of minimally invasive procedures, and leading manufacturers. The U.S. has a well-structured regulatory framework for medical devices and interventional oncology technologies, in which regulators approve and clear many ablation systems for specific medical applications. The country is also a key center for clinical studies and procedure development in microwave ablation, cryoablation, radiofrequency ablation, HIFU, and electroporation.

Asia Pacific is the fastest-growing region, reflecting a growing number of cancer patients and rapid development of healthcare systems. China, Japan, South Korea, and India are the most important markets, and all four are active in adopting new interventional oncology techniques and image-based technologies for treatment.

Europe, Latin America, and the Middle East & Africa complete the report’s regional coverage.

Market Segmentation Snapshot

The global tumor ablation market is segmented across product type, technology type, procedure type, application type, end user type, and region:

By Product Type:Systems (Radiofrequency Ablation Systems, Microwave Ablation Systems, Cryoablation Systems, Irreversible Electroporation Systems, Other Systems)Probes/Electrodes (Radiofrequency Ablation Probes, Microwave Ablation Probes, Other Probes/Electrodes)Consumables & AccessoriesOther Consumables & AccessoriesBy Technology Type:Radiofrequency AblationMicrowave AblationCryoablationIrreversible ElectroporationOther TechnologiesBy Procedure Type:Laparoscopic AblationPercutaneous AblationSurgical AblationBy Application Type:Lung CancerKidney CancerBone CancerLiver CancerOther ApplicationsBy End User Type:Hospitals & ClinicsCancer Care CentresAmbulatory Surgery CentresOther End UsersBy Region:North AmericaEuropeAsia-PacificLatin AmericaMiddle East & Africa

Frequently Asked Questions

Q: What is the size of the tumor ablation market? A: The global tumor ablation market is estimated at USD 1.04 billion in 2026 and is projected to reach USD 1.8 billion by 2031.

Q: What is the growth rate of the tumor ablation market? A: The tumor ablation market is projected to grow at a CAGR of 11.6% between 2026 and 2031.

Q: What is tumor ablation? A: Tumor ablation refers to minimally invasive procedures that destroy targeted tumor tissue using thermal, non-thermal, or energy-based techniques, including radiofrequency energy, microwave energy, cryogenic energy, focused ultrasound, laser energy, or electrical pulses, while minimizing damage to surrounding healthy tissue. Depending on the technology, procedures may be performed percutaneously, laparoscopically, or through other image-guided minimally invasive approaches.

Q: Which cancers are treated with tumor ablation? A: Established applications include liver, kidney, lung, and prostate tumors, with growing use in breast, bone, and other solid tumors. The state of the technology and the availability of clinical evidence vary from one application to another.

Q: Which technology leads the tumor ablation industry? A: Radiofrequency ablation held a leading position by technology type in 2025, supported by extensive clinical experience and wide availability, while microwave ablation is gradually gaining ground.

Q: Which product type leads the tumor ablation market? A: Systems held a leading position by product type in 2025, reflecting rising uptake of energy-based solutions for minimally invasive tumor treatment.

Q: Which region leads the tumor ablation market? A: North America held the largest share of the tumor ablation industry in 2025, while Asia Pacific is the fastest-growing region through 2031.

Q: Who are the top players in the tumor ablation market? A: Leading companies in the tumor ablation market include Medtronic plc, Boston Scientific Corporation, Johnson & Johnson, AngioDynamics, Inc., and IceCure Medical Ltd.

Ablation began as a way to destroy a tumor with a probe. The report points to a market where the probe is only part of the system, and imaging, planning, monitoring, and clinical evidence matter as much as the energy source. For manufacturers, the work ahead is delivering more predictable ablation zones near vital structures and building the evidence and training that newer techniques need.

View Pricing & License Options — Unlock Full Market Sizing & Competitive Benchmarking: https://www.wissenresearch.com/market-research-reports-pricings/tumor-ablation-market 

Expert Profile | Mayur Jain, Wissen Research 

Mayur Jain is a Research Expert at Wissen Research with multidomain expertise with more than 12+ years of experience in market research industry. 

Email: mayur@wissenresearch.com
LinkedIn:  https://www.linkedin.com/in/mayur-jain-0190542a/ 

About Wissen Research

Wissen Research is a global market intelligence and consulting firm specializing in healthcare, life sciences, technology, and emerging industries. The company provides data-driven insights, strategic market analysis, and industry forecasts to help organizations make informed business decisions and identify new growth opportunities across global markets

Company Contact:

Wissen Research LLC,
Gould St, Ste R,
Sheridan, WY 82801,
Phone: (+1) 510 240 9853
Email: info@wissenresearch.com
Website: https://www.wissenresearch.com/
Blog: https://www.wissenresearch.com/insights/
LinkedIn: https://www.linkedin.com/company/wissen-research 

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/tumor-ablation-market-set-to-surge-to-us-1-8-billion-by-2031–growing-at-11-6-cagr-wissen-research-302913088.html

Continue Reading

Technology

Harlem Children’s Zone Acquires FinTech Platform, Goalsetter, to Accelerate Universal Economic Mobility

Published

on

By

Acquisition combines HCZ’s proven model with Goalsetter’s innovative financial education technology to expand access and impact at scale

NEW YORK, Oct. 22, 2026 /PRNewswire/ — Today, Harlem Children’s Zone (HCZ), one of the nation’s leading anti-poverty organizations, announced the acquisition of Goalsetter, a financial technology platform that delivers best-in-class, engaging, technology-enabled learning experiences for people seeking to enhance their financial know-how, capabilities, and confidence.   

The acquisition marks a significant step in HCZ’s Wealth Builds–Universal Economic Mobility (WB-UEM) strategy, a national framework designed to help children and families build long-term economic security through cradle-to-career supports, financial education and experiences, and direct access to capital via a Child Capital Stack of asset boosts.

“We know that economic mobility is a two-generation challenge,” says Harlem Children’s Zone CEO Kwame Owusu-Kesse. “With this acquisition, we are solving for a critical component of Universal Economic Mobility by melding a proven financial education platform and HCZ’s decades of experience providing people with the knowledge and tools to build strong futures for themselves and their families. This is more than an investment in financial education. It is an investment in critical national infrastructure for economic mobility.”

Harlem Children’s Zone has decades of experience driving outcomes at scale, beginning as a one-block pilot, expanding to over 100 blocks in Central Harlem, and now working with over 70 communities across the United States. HCZ seeks to use its learnings, decades of experience driving outcomes at scale, and renowned best practices to provide pathways to economic mobility for all of America’s children and families.

“Goalsetter was built on the belief that everyone should have access to the financial knowledge and tools that can shape their future and livelihood,” said Tanya Van Court, Chief FinTech Officer at Harlem Children’s Zone and Founder of Goalsetter. “Joining Harlem Children’s Zone gives us an extraordinary opportunity to build on that work. Together, we can continue enhancing the platform, expand access for learners of all ages and walks of life, and demonstrate what is possible when mission, innovation, and technology come together to serve the most people.”

Goalsetter creates opportunities to deliver high-quality, developmentally appropriate and culturally relevant financial education with extensive reach,  including to low-income and rural communities that have historically had limited access to these resources. Its current offerings include Goalsetter Classroom, which provides standards-aligned financial education curriculum for middle and high school students, and MoneyLingo, a mobile-first financial education experience for college-aged students and adults in the workforce, covering practical topics such as saving, investing, credit, debt, and financial decision-making.                                                         

“This acquisition sends an important signal to the field,” said Owusu-Kesse. “Social impact organizations should not have to choose between mission and scale. By bringing a proven technology platform into HCZ, we’re demonstrating how non-profit organizations can be centers of business excellence, using vehicles of innovation, AI, and technology to create efficient and effective pathways to scale and impact. This acquisition strengthens our in-house capacity to build, innovate, and continuously improve outcomes.”

The organization plans to build upon Goalsetter’s existing offerings by exploring financial education products for younger learners and creating opportunities to establish a continuous financial learning journey from early childhood through adulthood.

“This is ultimately about extending opportunity to all,” added Owusu-Kesse. “By connecting financial education, technology, family engagement, and access to assets, we can help create more accessible pathways to economic mobility.”

Services to current Goalsetter clients will be unaffected by this acquisition.

View original content:https://www.prnewswire.com/news-releases/harlem-childrens-zone-acquires-fintech-platform-goalsetter-to-accelerate-universal-economic-mobility-302917320.html

SOURCE Harlem Children’s Zone

Continue Reading

Technology

Common Ground in the Battlegrounds? Surveys Reveal Widespread Bipartisan Agreement in 11 Competitive States and 28 Congressional Districts, as Well as Nationally

Published

on

By

Bipartisan Majorities Say If Congress Were to Listen to the People More, They Would More Likely Find Common Ground

COLLEGE PARK, Md., Oct. 22, 2026 /PRNewswire/ — The Program for Public Consultation (PPC) conducted extensive surveys in competitive states and congressional districts, as well as nationally, revealing a remarkable level of bipartisan common ground.

Majorities of both Democrats and Republicans agreed on: 

106 policies nationally 82 policies in all states and districts surveyed101 policies in at least two-thirds of all the states and districts surveyed

Over 40,000 Americans were surveyed in two waves with representative samples of 600-2,016 in each of the 11 competitive states surveyed, and 400-592 in each of the 28 competitive congressional districts surveyed, and 1,200-2,509 nationwide.

Nearly all policy questions were based on congressional legislation or executive branch proposals. 

Fourteen policy topics were covered: Artificial Intelligence, Housing, Healthcare, Low-Income Assistance, Families and Children, Social Security, Immigration, Abortion and Birth Control, Energy and Environment, Federal Taxes, Campaign Finance, Government Reform, Criminal Justice and America’s Role in the World. For every topic, most policies had bipartisan agreement across every battleground surveyed.

The policy questions used in these national and battleground surveys were chosen because they elicited bipartisan support in previous in-depth national surveys conducted by PPC, in which respondents received briefings on the topic and evaluated pro and con arguments for the proposed policy.

Steven Kull, director of PPC, comments, “What is striking here is that these surveys revealed widespread bipartisan agreement on over a dozen key issues that Congress has failed to resolve, from costs of healthcare, to risks of artificial intelligence, to Social Security’s impending insolvency, and many more. Clearly, there is far more common ground among the American people than there is in Congress.”

Americans Think Public Opinion Should Have More Influence
Respondents were also asked about the role of public opinion in policymaking. Across the battlegrounds, on average, respondents estimated that federally elected officials make the same decisions that the majority of Americans would make just 35% of the time.

Large majorities believe polarization in government comes not from the American people but from elected officials, and that more influence for the people would help break the logjam in Congress (Democrats 62 to 88%, Republicans 66 to 89%).

Perhaps most germane, overwhelming majorities of Democrats and Republicans in the battlegrounds believe that if members of Congress were more influenced by the people, they would be more likely to find common ground (Democrats 82 to 97%, Republicans 80 to 95%), and better serve the common good (Democrats 77 to 94%, Republicans 79 to 94%).

Steven Kull adds, “On the basis of this study, it does appear that the public is correct that if the people had more influence, Congress would be more likely to find common ground, and thus  function better.”

Americans also say that public opinion should play a substantial role in news reporting about policy. Over two-thirds say news reports on policy matters should include public opinion data most of the time or always when reliable information is available (Democrats 71 to 88%, Republicans 67 to 89%). Similarly, when Congress is about to vote on a law, large numbers say it is very or extremely important for news outlets to report whether a majority of Americans favor or oppose it (Democrats 65 to 84%, Republicans 60 to 85%).

MORE INFORMATION

Battlegrounds Common Ground SheetIndividual State and District Results, Questionnaires and MethodologiesNational Questionnaire with Toplines, Crosstabs and Methodology

About the Surveys
The state and district surveys used for this analysis were fielded July 21 – August 17, 2026, to a total of 19,949 adults, and May 27 – July 1, 2026, to 19,564 adults. They included 600-2016 in each of the 11 states, and 400-592 in each of the 28 congressional districts. Response rates ranged from 7.1 to 9.0%. Confidence intervals range from +/- 2.9 to 8.1%, and maximum weights range from 1.9 to 10.0.

The national surveys were fielded February 11-26, 2026, with 2,509 adults, and March 11-19, 2026, with 1,200 adults. The response rates were 7.6% and 8.3%, respectively. The confidence interval is +/- 2.9% for both surveys, and the maximum weights are 2.5 and 1.9.

The sample was obtained from multiple online opt-in panels, including Cint, Dynata and Prodege. Sample collection and quality control were managed by QuantifyAI under the direction of the Program for Public Consultation. The surveys were offered in both English and Spanish.

The samples were pre-stratified and weighted by age, race, ethnicity, gender, education, household income, marital status, and home ownership to match the general adult population. The national sample was further weighted by Census region. The distribution of partisan affiliation was within expectations, based on voter registration data for non-leaners and/or Cook’s Partisan Voting Index for leaners, or weighted to reflect those benchmarks.

About the Common Ground in the Battlegrounds? Survey Series
This effort aims to identify bipartisan common ground in competitive states and districts across the nation. The project seeks to educate the public, policymakers and candidates about the findings; and provide journalists with independent, nonpartisan research that brings the public into the conversation about public policy.

In addition to PPC, project partners include the Civic Innovation Center at the University of Maryland (CivIC) and Voice of the People (VOP), a national nonpartisan organization seeking to give the public a greater voice in government. None of these entities advocate for policy positions or endorse candidates.

States surveyed: Alaska; Georgia; Iowa; Maine; Michigan; Minnesota; Montana; Nebraska; New Hampshire; North Carolina; Ohio; and Texas.

Congressional Districts surveyed: Arizona’s 1st and 6th; Colorado’s 8th; Iowa’s 1st, 2nd, 3rd and 4th; Maine’s 2nd; Michigan’s 4th, 7th, 8th and 10th; Montana’s 1st; Nebraska’s 2nd; Nevada’s 3rd; New Jersey’s 7th and 9th; New Mexico’s 2nd; New York’s 3rd, 4th, 17th and 19th; Oregon’s 5th; Pennsylvania’s 1st, 7th, 8th and 10th; and Washington’s 3rd.

The survey series excluded several competitive districts because they were in states that had recently been redistricted and thus had no Census data yet to use for demographic benchmarks.

Program for Public Consultation
The Program for Public Consultation (PPC), affiliated with the University of Maryland’s School of Public Policy, seeks to improve democratic governance by consulting the public and bringing the people’s views into the public discourse. It conducts surveys with representative samples on policies proposed by elected officials and shares its findings with government officials, the media, other academics, and the general public.

Civic Innovation Center
The Civic Innovation Center (CivIC) at the University of Maryland’s School of Public Policy works to strengthen the foundations of civic health. It contributes to important debates about civic education, civic engagement, and needed democratic reforms in the state of Maryland and nationwide, in partnership with other BIG 10 universities. It works to build the connective tissue that brings together students, scholars and practitioners to help elevate the UMD community’s contribution to our wider democracy.

Voice of the People
Voice of the People (VOP) is a nonpartisan organization working to re-anchor our democracy in its founding principles by giving ‘We the People’ a greater and more effective voice in government. It champions innovative methods and technology that enable the American people to play a role in the policymaking process and provide policymakers with a more accurate understanding of the views of their constituents.

Contact: Jonathan Casaverde, jonathan.casaverde@wardcirclestrategies.com,(786) 469-9422

View original content to download multimedia:https://www.prnewswire.com/news-releases/common-ground-in-the-battlegrounds-surveys-reveal-widespread-bipartisan-agreement-in-11-competitive-states-and-28-congressional-districts-as-well-as-nationally-302915872.html

SOURCE Program for Public Consultation

Continue Reading

Technology

FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform

Published

on

By

Anatomy segmentation and three-dimensional skeletal visualization arrive with this clearance; an injury detection module for clinical decision support is in development on the platform roadmap

CHARLOTTESVILLE, Va., Oct. 22, 2026 /PRNewswire/ — RIVANNA®, developer of AI-enabled clinical decision-support solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for BoneEnhance®, a machine learning software module for the Accuro® XV diagnostic ultrasound system. The module segments bone and surrounding tissues and supports visualization of skeletal anatomy in three dimensions during image review.

The clearance moves the platform from acquisition toward interpretation. Accuro XV was cleared in April 2026 for B-mode imaging in musculoskeletal conventional and superficial applications. Its conformable three-dimensional probe automates large field-of-view image acquisition after initial patient positioning. BoneEnhance is the first machine learning software module cleared for the platform.

BoneEnhance identifies bone and surrounding tissues

Each automated acquisition creates a volumetric dataset for review. BoneEnhance identifies bone and surrounding tissues within that volume, then highlights them with color-coded overlays on the two-dimensional B-mode image. The original anatomical data remain unaltered and visible beneath the overlays. A three-dimensional indicator beside the image shows the scan orientation and the location of the displayed slice within the volume.

A platform milestone

The sequence is deliberate: decision support begins at acquisition. Accuro XV acquires the image; BoneEnhance identifies and labels the anatomy within it. Behind the integrated workflow stands a worldwide intellectual-property portfolio of more than 100 issued and pending patents across more than 20 patent families.

“We founded RIVANNA to solve a problem that cuts across care settings: decision-critical information sits outside the point-of-care workflow,” said Will Mauldin, PhD, Co-founder and CEO of RIVANNA. “BoneEnhance is where the stack begins to close that gap for musculoskeletal care: automated volumetric acquisition, now paired with cleared software-assisted review. This clearance is the foundation: the first machine learning layer, anchoring the decision-support capabilities now in development.”

Independently validated within a nationwide eight-site study

BoneEnhance was trained and validated within RIVANNA’s nationwide eight-site clinical study. Three sites contributed the training data; the other five provided the independent test set of 233 volumetric datasets, comprising 69,900 images from 173 subjects. None of the test data were used for training or tuning. Three board-certified radiologists established the reference labels, and per-volume label prediction accuracy, a measure of anatomical labeling, ranged from 95.1% to 100.0%.

Separate from the validation supporting this clearance, the platform’s automated acquisition carries peer-reviewed evidence: in a published study of 205 patients in the Journal of Emergency Medicine (DOI: 10.1016/j.jemermed.2025.11.011), operators with one hour of hands-on training acquired wrist and ankle images rated adequate for diagnostic interpretation in more than 90% of scans, with image quality comparable to physician-acquired scans.

“This clearance reflects the strength of the team RIVANNA has built across AI development, clinical affairs, and regulatory execution, and the commitment of the clinical sites that partnered with us to generate the evidence,” said Delphine Le Roux, PhD, PMP, Senior Director, Market Access and Strategic Partnerships at RIVANNA. “None of it happens without BARDA’s sustained support, which allowed us to do this the right way: rigorous, multi-site, and independent. The infrastructure, partnerships, and regulatory playbook we established for BoneEnhance are designed to carry forward. That execution engine is what positions us to pursue the next clearance with confidence.”

The next layer in development

The platform’s progression continues with an investigational musculoskeletal injury detection module. Where BoneEnhance labels the anatomy, the new module is being developed to assist clinicians in evaluating potential extremity fractures within acquired ultrasound images. The nationwide clinical study that trained and validated BoneEnhance, now expanded from eight to ten sites, is building the datasets used to train the module. Because the sites and data infrastructure were established once and are reused for each new module, every subsequent module builds on the program’s federal investment.

Federal funding acknowledgment

This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; the Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number 75A50121C00035.

About Accuro XV

Accuro XV is a portable, small-footprint point-of-care volumetric ultrasound imaging system for musculoskeletal imaging. Its conformable three-dimensional probe automates large field-of-view B-mode image acquisition without ionizing radiation. BoneEnhance is a cleared machine learning software module available during review of Accuro XV volumetric image acquisitions. It segments bone and surrounding tissues and supports visualization of skeletal anatomy in three dimensions.

An investigational computer-aided musculoskeletal injury detection module is in development for Accuro XV. It is designed to assist clinicians in detecting extremity fractures from volumetric ultrasound and annotating soft-tissue signs associated with injury, and to support triage decisions, including referral for additional radiographic imaging.

Accuro XV is designed to provide a fracture-care layer at the point of triage, helping to streamline emergency department workflows, expedite evaluation of low-severity extremity injuries, and reduce reliance on X-ray referrals. The platform is designed to support just-in-time training to promote consistent use across clinical experience levels, advancing a shared mission to transform musculoskeletal injury care while supporting broader emergency preparedness objectives.

About RIVANNA

RIVANNA is a medical technology company developing clinical decision-support solutions powered by proprietary clinical datasets, AI models, and purpose-built imaging hardware. The company’s platform is designed to automate complex anatomical analysis at the point of care, support faster and more confident clinical decisions, reduce variability, and expand access to advanced capabilities. Its initial applications address interventional guidance and trauma triage, beginning with neuraxial procedures and musculoskeletal injury assessment. RIVANNA has established an FDA-cleared product portfolio and maintains a worldwide intellectual-property portfolio of more than 100 issued and pending patents. RIVANNA is headquartered in Charlottesville, Virginia, and operates an FDA-registered, ISO 13485:2016-certified manufacturing facility.

RIVANNA, Accuro, BoneEnhance, and the Rivanna Medical family of marks are registered and unregistered trademarks of Rivanna Medical, Inc. in the United States and other jurisdictions.

View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-grants-510k-clearance-for-boneenhance-the-first-machine-learning-layer-on-rivannas-accuro-xv-platform-302917179.html

SOURCE RIVANNA

Continue Reading

Trending