Technology
TNL Mediagene Pursues Cost-Efficient Expansion with New C-Level Hires and Strategic M&A Focus
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1 year agoon
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NEW YORK and TOKYO, May 7, 2025 /PRNewswire/ — TNL Mediagene (Nasdaq: TNMG), a Tokyo-based next-generation digital media and data group in Asia, today announced its Strategic Expansion Plan comprising two pillars, Global Talent Management and Global Strategic M&A. The plan, spanning the next 24-month period, outlines the company’s focus on cost-efficient revenue growth, toward its goal of continued growth in revenue while further improving Adjusted EBITDA.
As part of its Global Talent Management pillar, the company announced the appointment of Aya Miyake as Chief Governance Officer and Carly Ma as Chief Human Resources Officer.
Aya Miyake brings over two decades of capital markets and business experience including executive roles at Tokyo Stock Exchange, Osaka Securities Exchange and Automotive Fund. Aya’s extensive experience includes corporate governance, public listings, capital raising, investor relations and compliance. Aya’s role as Chief Governance Officer at TNL Mediagene will strengthen the company’s expertise in public company matters and bolster its C-level oversight and control functions.
Carly Ma brings over a decade of HR experience at multinational corporations with roles at Porsche Taiwan Motors, a subsidiary of Porsche A.G. Germany, Amazon Fulfillment Services and Amazon Canada. Carly’s experience includes talent acquisition, talent optimization and corporate culture development programs. Carly’s experience at multinational companies will strengthen TNL Mediagene’s talent acquisition and talent optimization functions and align the company’s practices with best-practice international standards.
“Aya’s wealth of experience in the capital markets and adjacent areas will bolster our institutional knowledge in all areas of public company matters as well as enhance our C-level oversight and control functions. Carly’s experience in multinational corporate HR will bring HR best practices to our company, help us acquire and retain talent as well as optimize our talent pool going forward. We are thrilled to welcome them to the TNL Mediagene family” Co-Founder & CEO Joey Chung said.
As part of the Global Strategic M&A pillar, the company gave an update on its M&A strategy including its focus on enhancing revenue growth and revenue diversification via M&A. The company’s geographic focus areas for strategic expansion include the Southeast Asia, Japan and Taiwan markets where the company sees the highest ROI and synergy potential as well as English language markets such as the US, Canada, UK and Australia.
“M&A has been a part of our DNA for some time now. We have acquired and integrated 10 companies since 2018 and maintain an active pipeline of M&A opportunities. We have close relationships with our bankers and continue to actively screen targets with them. In the near-term we see opportunities in Southeast Asia, Japan and Taiwan and in the medium to longer-term we see opportunities in the US and other English language markets. Right now, we are most focused on assets that are complementary to our current businesses or assets where we can add value and enhance with our relative strengths in technology products, multilingualization or cost discipline. These can include, for example, assets with large regional audiences but less sophisticated tech, assets with a solid offering that we can expand into a new language market with our multilingualization strategies or assets where we can add value by taking cost out using our cost discipline strategies.”
TNL Mediagene believes M&A is a key component of its financial performance and intends to be acquisitive going forward.
“In FY2024 we achieved 35% revenue growth, a ~1% gross margin expansion to 36.6%, and a ~1% Adjusted EBITDA margin expansion to near break-even at -1.8%. We are proud of these results and believe they are a testament to our ability to grow our revenues while running our businesses in a cost-efficient manner. Strategic M&A has always been a part of that equation and we expect that to continue going forward” Joey concluded.
Summary Financials:
For the year ended December 31,
($ in dollars, unless otherwise stated)
2022
2023
2024
Revenue
20,009,994
35,838,780
48,493,897
Growth %
79.1 %
35.3 %
Gross Profit
7,741,196
12,651,384
17,738,557
Margin %
38.7 %
35.3 %
36.6 %
Adjusted EBITDA
-1,687,729
-998,162
-854,174
Margin %
-8.4 %
-2.8 %
-1.8 %
The condensed financial information presented in this press release should be read in conjunction with the audited consolidated financial statements and related notes for the year ended December 31, 2024 included in TNL Mediagene’s annual report on Form 20-F filed with the SEC on April 30, 2025, which provides a more complete discussion of its accounting policies and certain other information.
About TNL Mediagene
Headquartered in Tokyo, TNL Mediagene was formed in May 2023 through the merger of Taiwan’s The News Lens Co. and Japan’s Mediagene Inc., two of the region’s leading independent digital media groups. The company’s operations span original and licensed media brands in Japanese, Chinese, and English, covering topics such as news, business, technology, science, food, sports, and lifestyle. It also offers AI-driven advertising services, marketing technology platforms, e-commerce, and innovative solutions tailored to the needs of advertising agencies. Known for its political neutrality, appeal to younger audiences, and high-quality content, TNL Mediagene has approximately 500 employees across Asia, with offices in Japan, Taiwan, and Hong Kong.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are based on beliefs and assumptions and on information currently available to TNL Mediagene. Forward-looking statements generally relate to future events or TNL Mediagene’s future financial or operating performance. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing,” “target,” “seek” or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Forward-looking statements in this communication include, but are not limited to, statements in the section entitled “2025 Initiatives and Outlook” and “Management Commentary” such as statements about TNL Mediagene’s future business plan and growth strategies and statements by TNL Mediagene’s CEO and president. Any statements that refer to expectations, projections or other characterizations of future events or circumstances, including strategies or plans, are also forward-looking statements. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Forward-looking statements in this communication or elsewhere speak only as of the date made. New uncertainties and risks arise from time to time, and it is impossible for TNL Mediagene to predict these events or how they may affect TNL Mediagene. In addition, risks and uncertainties are described in TNL Mediagene’s filings with the Securities and Exchange Commission. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. TNL Mediagene cannot assure you that the forward-looking statements in this communication will prove to be accurate. There may be additional risks that TNL Mediagene presently does not know or that TNL Mediagene currently does not believe are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by TNL Mediagene, its directors, officers or employees or any other person. Except as required by applicable law, TNL Mediagene does not have any duty to, and does not intend to, update or revise the forward-looking statements in this communication or elsewhere after the date of this communication. You should, therefore, not rely on these forward-looking statements as representing the views of TNL Mediagene as of any date subsequent to the date of this communication.
Use of Non-IFRS Financial Measures
In this press release we have included adjusted EBITDA, a non-IFRS financial measure, which is a key measure used by our management and board of directors in evaluating our operating performance.
Adjusted EBITDA is our preferred metric for profitability because we believe it facilitates operating performance comparisons on a period-to-period basis and excludes items that we do not consider to be indicative of our core operating performance.
Adjusted EBITDA has limitations as an analytical tool, and you should not consider it in isolation or as a substitute for analysis of our results as reported under IFRS. Some of these limitations are:
although amortization and depreciation are non-cash charges, the assets being amortized and depreciated may have to be replaced in the future, and adjusted EBITDA does not reflect cash capital expenditure requirements for such replacements or for new capital expenditure requirements;adjusted EBITDA does not reflect changes in, or cash requirements for, our working capital needs;adjusted EBITDA does not reflect the potentially dilutive impact of equity-based compensation; andother companies, including our competitors in various industries, may calculate adjusted EBITDA or similarly titled measures differently, which reduces its usefulness as a comparative measure.
We define adjusted EBITDA as profit (loss) for the period excluding (i) non-cash items such as depreciation expenses, amortization expenses, stock-based compensation expenses and impairment loss on intangible assets and (ii) extraordinary items associated with one-time events and transactions, such as one-time transaction-related expenses not eligible for capitalization.
Reconciliation of Non-IFRS Financial Measures:
For the year ended December 31,
($ in dollars, unless otherwise stated)
2022
2023
2024
Loss for the year
$
(11,394,768)
$
(1,215,789)
$(84,976,720)
Add (less):
Income tax (benefit) expense
(247,177)
(591,082)
(307,246)
Finance costs
137,029
298,958
8,167,872
Other gains and losses(1)
8,174,802
(5,458,803)
851,689
Other income
(75,576)
(409,555)
(58,024)
Interest Income
(10,994)
(19,340)
(21,773)
Operating loss
$
(3,416,684)
$
(7,395,611)
$(76,344,202)
Add:
Depreciation expenses
433,262
1,025,783
1,139,488
Amortization expenses
1,058,392
1,809,774
2,101,080
Stock-based compensation expense
237,301
118,800
250,952
Impairment loss on intangible assets(2)
—
298,424
29,026,050
One-time transaction-related expenses(3)
—
3,144,668
42,972,458
Adjusted EBITDA
(1,687,729)
(998,162)
(854,174)
Adjusted EBITDA Margin (%)
-8.4
%
-2.8
%
-1.8
%
(1)
Other gains and losses for the year ended December 31, 2022 comprise an $8.2 million loss mainly attributed to a change in the fair value through profit and loss (“FVPTL”) associated with our convertible preference shares. Other gains and losses for the year ended December 31, 2023 comprise a $5.5 million gain mainly attributed to a change in the FVPTL associated with the conversion of all of our preference shares into our ordinary shares at a lower fair value during the year ended December 31, 2023. Other gains and losses for the year ended December 31, 2024 comprise a $0.8 million loss mainly attributed to a change in FVTPL associated with the convertible promissory note and warrants.
(2)
For the year ended December 31, 2023, we incurred approximately $0.3 million of impairment loss on intangible assets due to the closure of our e-commerce platform CoSTORY as the internally-developed software on which CoSTORY relied became no longer recoverable. For the year ended December 31, 2024, we incurred impairment loss on intangible assets of approximately $29.0 million, which mainly consisted of (i) an impairment loss of $25.5 million against the goodwill of Mediagene recognized because, following the merger with Mediagene in May 2023 and during subsequent operations in 2024, it became evident that the anticipated synergies fell short of initial expectations due to changes in the overall environment, necessitating adjustments to the financial projections and, as a result of this downward revision in projected future revenues, the fair value declined, leading to the recognition of an impairment loss and (ii) an impairment loss of $3.1 million due to the downsizing of the e-commerce department of Polydice Inc.
(3)
For the year ended December 31, 2023, one-time transaction-related expenses comprise the professional service fees related to (i) the merger with Mediagene; and (ii) preparation for our merger (the “Merger”) with Blue Ocean Acquisition Corporation (“Blue Ocean”) and the listing on the Nasdaq, which were not eligible for capitalization. For the year ended December 31, 2024, one-time transaction-related expenses comprise (i) the professional service fees related to the closing of the Merger and listing on the Nasdaq of $4.3 million; (ii) the professional service fees related to the acquisition of Green Quest Holdings, Inc. of $0.5 million; and (iii) the listing expense of $38.2 million from the excess of the fair value of TNL Mediagene Ordinary Shares issued over the fair value of Blue Ocean’s identifiable net assets on the Closing Date of the Merger, each of which was not eligible for capitalization.
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SOURCE TNL Mediagene
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Technology
Harlem Children’s Zone Acquires FinTech Platform, Goalsetter, to Accelerate Universal Economic Mobility
Published
37 minutes agoon
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
Technology
Common Ground in the Battlegrounds? Surveys Reveal Widespread Bipartisan Agreement in 11 Competitive States and 28 Congressional Districts, as Well as Nationally
Published
37 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
Technology
FDA grants 510(k) clearance for BoneEnhance, the first machine learning layer on RIVANNA’s Accuro XV platform
Published
37 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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