Technology
In-Vitro Diagnostics Instruments Market size is set to grow by USD 52.9 billion from 2024-2028, Growing geriatric population boost the market, Technavio
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2 years agoon
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NEW YORK, July 31, 2024 /PRNewswire/ — The global in-vitro diagnostics instruments market size is estimated to grow by USD 52.9 billion from 2024-2028, according to Technavio. The market is estimated to grow at a CAGR of 9.29% during the forecast period. Growing geriatric population is driving market growth, with a trend towards potential opportunities for physician office laboratories (POL). However, strained laboratory budgets and lowering reimbursements affecting instrument sales poses a challenge. Key market players include Abbott Laboratories, Becton Dickinson and Co., Bio Rad Laboratories Inc., bioMerieux SA, Biosino Bio Technology and Science Inc, CPC Diagnostics Pvt Ltd., DAAN Gene Co. Ltd., Danaher Corp., F. Hoffmann La Roche Ltd., Guangzhou Wondfo Biotech Co. Ltd., Hologic Inc., Myriad Genetics Inc., QIAGEN NV, QuidelOrtho Corp., Shanghai Kehua Bio Engineering Co. Ltd, Shenzhen Mindray BioMedical Electronics Co. Ltd, Siemens AG, Sysmex Corp., and Thermo Fisher Scientific Inc..
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In-Vitro Diagnostics Instruments Market Scope
Report Coverage
Details
Base year
2023
Historic period
2017 – 2021
Forecast period
2024-2028
Growth momentum & CAGR
Accelerate at a CAGR of 9.29%
Market growth 2024-2028
USD 52.9 billion
Market structure
Fragmented
YoY growth 2022-2023 (%)
8.25
Regional analysis
North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution
North America at 33%
Key countries
US, Germany, China, Canada, and UK
Key companies profiled
Abbott Laboratories, Becton Dickinson and Co., Bio Rad Laboratories Inc., bioMerieux SA, Biosino Bio Technology and Science Inc, CPC Diagnostics Pvt Ltd., DAAN Gene Co. Ltd., Danaher Corp., F. Hoffmann La Roche Ltd., Guangzhou Wondfo Biotech Co. Ltd., Hologic Inc., Myriad Genetics Inc., QIAGEN NV, QuidelOrtho Corp., Shanghai Kehua Bio Engineering Co. Ltd, Shenzhen Mindray BioMedical Electronics Co. Ltd, Siemens AG, Sysmex Corp., and Thermo Fisher Scientific Inc.
Market Driver
In-Vitro Diagnostics (IVD) instruments market growth is driven by the increasing adoption of Point of Care (POL) testing in primary and outpatient care. POL testing, particularly in infectious disease markers, cardiovascular diseases, and diabetes care, is gaining popularity due to its convenience and quick results. Portable IVD instruments are advancing technically, enabling clinicians to perform tests in-house. The CLIA testing for molecular assays in POL practices is expected to fuel market growth. However, certain regulatory aspects regarding CLIA-waived testing may impact market expansion. Despite these challenges, the global IVD instruments market is projected to experience average growth due to the increasing trend towards POL testing.
The In Vitro Diagnostics Instruments Market is experiencing significant growth due to the rising demand for accurate and rapid medical tests. With a focus on infectious diseases such as Malaria and Chikungunya, the market is seeing increased adoption of advanced technologies like Next-Generation Sequencing (NGS) for pathogen detection. Laboratory technicians play a crucial role in this sector, handling various samples like blood, serum, plasma, urine, saliva, and tissues. Blood banks, home care settings, pharmaceutical companies, biotechnology firms, academic institutes, and non-communicable disease segments are key end-users. Infectious diseases and chronic conditions including cardiology, gastroenterology, and cancer are major application areas. The aging population and the rise of molecular diagnostics for diseases like Alzheimer’s and various cancers further fuel market expansion. In vitro diagnostics instruments offer efficiency, accuracy, and convenience in the laboratory environment, making them an essential tool for healthcare providers.
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Market Challenges
In the In-Vitro Diagnostics Instruments Market, reimbursement policies for diagnostic testing vary across geographies and are trending downward. This puts pressure on hospitals and diagnostic laboratories to reduce expenditure on IVD instruments to maintain revenue. Workforce shortages and lost health insurance cards lead to fewer patient visits and limited testing volumes. Lean laboratories are emerging in some countries, prioritizing essential capital equipment purchases. Reduced reimbursements for certain instruments, such as SMBG in Europe and IVD instruments in the US, impact sales growth. IVD companies respond by focusing on emerging markets and adapting to market conditions. These factors are expected to restrict the growth of the global IVD Instruments Market during the forecast period.The In-Vitro Diagnostics (IVD) Instruments Market is experiencing significant growth due to advances in Next Generation Sequencing, Liquid Biopsy, and Personalized Medicine. Genetic and molecular diagnostic technologies are driving innovation in Clinical Profiles, Companion Diagnostics, and various disease areas such as Hospitals and Healthcare Facilities. IVD equipment in Immunodiagnostics, Hematology, Tissue Diagnostics, Clinical Chemistry, and Cardiac Diseases are in high demand. Challenges include Norovirus, HIV, Lyme disease, and other infectious diseases. Reagents and kits, Software and Services, and Manufacturing Technology are essential components of this market. Diabetes, Oncology, Sexually Transmitted Diseases, and Geriatric Population are key applications. Distribution channels include hypermarkets, pharmacies, drug stores, online providers, standalone laboratories, and Clinical Laboratories. Tropical diseases and Endocrine Disorders are also targeted markets. High blood cholesterol, Heart Disease, Stroke, and Chronic Conditions are significant disease areas.
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Segment Overview
This in-vitro diagnostics instruments market report extensively covers market segmentation by
Product 1.1 Immunochemistry1.2 Clinical microbiology1.3 Molecular diagnostics1.4 OthersEnd-user 2.1 Hospitals and diagnostic laboratories2.2 Academic and research institutes2.3 Home careGeography 3.1 North America3.2 Europe3.3 Asia3.4 Rest of World (ROW)
1.1 Immunochemistry- The In-Vitro Diagnostics (IVD) Instruments Market’s highly automated segment of clinical laboratories holds the largest test volume compared to others. However, the demand for immunochemistry analyzers is declining in the US and Europe due to consolidation in France, late payments from Italy, Spain, and Portugal, and reductions in expenditure in the UK, France, and Germany. In contrast, the rise of rural hospitals in China and India lacking basic diagnostics infrastructure presents a growth opportunity. Over 80 immunoassay analyzer models are available, with manufacturers responding to competition through frequent new launches or analyzer upgrades. Reduced European reimbursement is attributed to delayed spending by some medical laboratories, while the Affordable Care Act (ACA) provides greater certainty for investments. IVDs, like Ortho Clinical Diagnostics’ VITROS immunodiagnostic products for HIV-1+2 detection, aid in early COVID-19 virus detection. Roche Diagnostics received FDA approval for the first HIV-1/HIV-2 qualitative test on cobas 6800/8800 systems. Innovative products and advanced technologies continue to enter the market, intensifying competition during the forecast period.
For more information on market segmentation with geographical analysis including forecast (2024-2028) and historic data (2017-2021) – Download a Sample Report
Research Analysis
In vitro diagnostics refer to medical tests conducted outside of a living organism, using samples of bodily fluids, tissues, or other specimens. These tests play a crucial role in the detection and diagnosis of various diseases, including infectious diseases such as Zika, Malaria, and Chikungunya, as well as chronic conditions like cardiovascular diseases, cancer, and endocrine disorders. The laboratory environment is essential for the accurate and reliable performance of these tests. In vitro diagnostics are used extensively in clinical laboratories to diagnose non-communicable diseases such as heart disease, stroke, high blood cholesterol, and Alzheimer’s disease. Molecular diagnostics and pathogen detection are advanced areas of in vitro diagnostics, offering rapid and accurate results for the diagnosis of various conditions. Laboratory technicians play a vital role in the collection, preparation, and analysis of samples for in vitro diagnostic tests. In vitro diagnostics are used in various medical specialties, including cardiology, gastroenterology, and neurology, to aid in the early detection and treatment of diseases.
Market Research Overview
In Vitro Diagnostics Instruments Market: Overview The In Vitro Diagnostics Instruments Market refers to the industry that produces and supplies diagnostic tools and equipment used in medical laboratories for analyzing samples derived from bodily fluids, tissues, and other specimens. These diagnostic instruments play a crucial role in detecting various diseases, including infectious diseases such as Norovirus, HIV, Lyme disease, and Shigellosis, chronic conditions like diabetes, cardiovascular diseases, cancer, and Alzheimer’s disease, and genetic disorders. The market caters to various end-users, including hospitals, healthcare facilities, pharmacies, drug stores, online providers, standalone laboratories, and clinical laboratories. The In Vitro Diagnostics Instruments Market encompasses a wide range of diagnostic technologies, including Immunodiagnostics, Hematology, Tissue Diagnostics, Clinical Chemistry, Cardiac Diseases, Immune System Disorders, Nephrological Diseases, Gastrointestinal Diseases, and others. The market is segmented into various product categories, including IVD equipment, Diagnostic Technologies, Reagents and Kits, Software and Services, and Molecular Diagnostics. Molecular Diagnostics further includes Next-Generation Sequencing (NGS), Liquid Biopsy, and Personalized Medicine. The market is also influenced by various factors such as the aging population, the rise in non-communicable diseases, and the increasing prevalence of chronic conditions. The In Vitro Diagnostics Instruments Market is driven by the growing demand for early and accurate diagnosis, the increasing focus on personalized medicine, and the increasing adoption of advanced diagnostic technologies such as NGS, liquid biopsy, and companion diagnostics. The market is also expected to witness significant growth due to the increasing prevalence of diseases such as diabetes, cancer, and cardiovascular diseases, and the growing awareness and acceptance of genetic testing. The market is highly competitive, with various players offering a wide range of diagnostic instruments and solutions. The market is also witnessing significant innovation, with new technologies and products being developed to address the evolving needs of healthcare providers and patients. Some of the key trends in the market include the increasing use of automation, the integration of artificial intelligence and machine learning, and the growing focus on point-of-care testing. The In Vitro Diagnostics Instruments Market is expected to grow at a significant CAGR during the forecast period, driven by the increasing demand for accurate and timely diagnosis, the growing prevalence of chronic diseases, and the increasing adoption of advanced diagnostic technologies. The market is also expected to be influenced by various factors such as regulatory frameworks, reimbursement policies, and technological advancements. In conclusion, the In Vitro Diagnostics Instruments Market plays a vital role in the healthcare industry by providing accurate and timely diagnosis, enabling personalized medicine, and contributing to better patient outcomes. The market is highly dynamic and is expected to witness significant growth in the coming years, driven by various factors such as the increasing prevalence of chronic diseases, the growing focus on personalized medicine, and the increasing adoption of advanced diagnostic technologies.
Table of Contents:
1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation
ProductImmunochemistryClinical MicrobiologyMolecular DiagnosticsOthersEnd-userHospitals And Diagnostic LaboratoriesAcademic And Research InstitutesHome CareGeographyNorth AmericaEuropeAsiaRest Of World (ROW)
7 Customer Landscape
8 Geographic Landscape
9 Drivers, Challenges, and Trends
10 Company Landscape
11 Company Analysis
12 Appendix
About Technavio
Technavio is a leading global technology research and advisory company. Their research and analysis focuses on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions.
With over 500 specialized analysts, Technavio’s report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavio’s comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.
Contacts
Technavio Research
Jesse Maida
Media & Marketing Executive
US: +1 844 364 1100
UK: +44 203 893 3200
Email: media@technavio.com
Website: www.technavio.com/
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SOURCE Technavio
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Harlem Children’s Zone Acquires FinTech Platform, Goalsetter, to Accelerate Universal Economic Mobility
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October 22, 2026By
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
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Common Ground in the Battlegrounds? Surveys Reveal Widespread Bipartisan Agreement in 11 Competitive States and 28 Congressional Districts, as Well as Nationally
Published
50 minutes agoon
October 22, 2026By
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
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SOURCE Program for Public Consultation
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FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform
Published
50 minutes agoon
October 22, 2026By
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.
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SOURCE RIVANNA
Harlem Children’s Zone Acquires FinTech Platform, Goalsetter, to Accelerate Universal Economic Mobility
Common Ground in the Battlegrounds? Surveys Reveal Widespread Bipartisan Agreement in 11 Competitive States and 28 Congressional Districts, as Well as Nationally
FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform
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