Connect with us

Technology

Data Center Air Filtration Market to Reach USD 1.19 Billion by 2035 as Replacement Filters and Gas-Phase Media Drive Recurring Spend – DC Market Insights

Published

on

Market grows at an 8.59% CAGR from USD 520.20 million in 2025; replacement filters hold 78.3% of spending and gas-phase filtration grows fastest at 11.16% a year

LONDON, Oct. 20, 2026 /PRNewswire/ — The “Data Center Air Filtration Market – Growth, Share, Opportunities & Competitive Analysis, 2026-2035” report has been added to the DC Market Insights offering. The global Data Center Air Filtration Market was valued at USD 520.20 million in 2025, is estimated at USD 589.74 million in 2026, and is projected to reach USD 1.19 billion by 2035, growing at a CAGR of 8.59% from 2025 to 2035. DC Market Insights finds that this is primarily a recurring consumables market: replacement filters and media account for 78.3% of 2025 value, while liquid cooling slows first-fit demand by moving more AI rack heat away from the room air path.

Data Center Air Filtration Market at a Glance

Metric

Value (DC Market Insights estimate)

Market size, 2020

USD 314.90 million

Market size, 2025 (base year)

USD 520.20 million

Market size, 2026

USD 589.74 million (+13.4% year on year)

Market size, 2030

USD 843.18 million

Market size, 2035

USD 1.19 billion

CAGR 2025-2035

8.59% (low case 7.55%, high case 9.78%)

Largest filter type

Fine filters, 38.0% of 2025 value

Fastest-growing filter type

Gas-phase filtration, 11.16% CAGR

Leading region

North America, 39.0% (USD 202.87 million)

Fastest-growing region

Middle East and Africa, 12.13% CAGR

Market leader

Camfil, about 15% of 2025 value

Key Takeaways

USD 407.26 million, or 78.3% of 2025 value, is replacement spending because filters on the installed air-handled base are changed one to two times a year.The fleet-average filter bill is about USD 3,600 per MW of air-handled IT load a year in 2025.Gas-phase filtration grows 11.16% a year as operators manage corrosive gases and ASHRAE G1 limits in polluted and industrial hubs.Outside-air economizer intakes account for 27.0% of 2025 value and grow 10.10% a year as more sites use free-air cooling.Liquid cooling restrains first-fit demand: new-build first-fit filters grow 5.48% a year while replacement filters and media grow 9.33%.

Scope & Segmentation – Data Center Air Filtration Market

The report analyzes the market across the following segments:

Filter Type: Pre-Filters; Fine Filters; HEPA and EPA Filters; Gas-Phase Filtration; Housings, Frames and Pressure MonitoringApplication: CRAH/CRAC and Fan-Wall Recirculation; Outside-Air Economizer Intakes; Make-Up Air and Pressurization Units; Generator, Battery and Electrical RoomsPurchase Type: First-Fit with New Builds; Replacement Filters and MediaData Center Type: Hyperscale and AI Cloud Data Centers; Colocation Data Centers; Enterprise and Edge Data CentersGeography: North America; Europe; Asia Pacific; Latin America; Middle East and Africa, with 12 country forecasts

Report Updated: Oct. 20, 2026

Get Free Sample Report – Data Center Air Filtration Market

“Data center air filtration is increasingly an installed-base business. Liquid cooling reduces the air path in new AI halls, but hundreds of gigawatts of air-handled capacity still need recurring filter changes, and polluted or corrosive locations require more expensive fine and gas-phase media. That makes replacement contracts, pressure monitoring and chemical filtration the most defensible growth pools through 2035.”

— Amit Jain, Senior Consultant, ICT & Emerging Technologies, DC Market Insights, report author

Why This Report Matters

Air filtration sits at the intersection of equipment reliability, free-air cooling efficiency and contamination control. The report helps filter manufacturers, cooling vendors, data center operators, hyperscalers, colocation providers and investors size first-fit and replacement demand, compare filter classes and identify geographies where dust, smoke and corrosive gases raise lifecycle spending.

Key Attributes

Report attribute

Details

Historical Period

2020-2024

Base Year

2025

Forecast Period

2026-2035

Market Size 2025

USD 520.20 million

Market Size 2026

USD 589.74 million (+13.4% year on year)

Market Size 2035

USD 1.19 billion

CAGR 2025-2035

8.59% (low case 7.55%, high case 9.78%)

Leading Region

North America, 39.0% (USD 202.87 million)

Report Format

PDF + Excel

How Big Is the Data Center Air Filtration Market in 2026?

DC Market Insights values the Data Center Air Filtration Market at USD 589.74 million in 2026, 13.4% above 2025, as new capacity receives first-fit filters and the air-handled installed base continues to expand. The market remains tied more closely to replacement cycles than to new construction alone.

Year

Market size

2020

USD 314.90 million

2025

USD 520.20 million

2026

USD 589.74 million (+13.4% year on year)

2030

USD 843.18 million

2035F

USD 1.19 billion

Source: DC Market Insights, Data Center Air Filtration Market report, Oct. 20, 2026.

Why Does Replacement Spending Outgrow First-Fit Demand?

Liquid cooling removes a growing share of AI rack heat from the room air path, which limits the volume of first-fit filters required per new megawatt. Replacement demand behaves differently: existing air-cooled and hybrid halls continue to change pre-filters, fine filters and gas-phase media according to pressure drop, contamination and operating conditions. DC Market Insights therefore models replacement filters and media growing 9.33% a year, compared with 5.48% for first fit.

Which Filter Type Leads Data Center Air Filtration Spending?

Fine filters lead 2025 spending with 38.0% of market value, while gas-phase filtration grows fastest as operators manage sulfur dioxide, hydrogen sulfide and other corrosive contaminants around industrial and urban locations.

Filter type

2025 value

Share 2025

2035 value

CAGR

Pre-Filters

USD 109.24M

21.0 %

USD 213.46M

6.93 %

Fine Filters

USD 197.68M

38.0 %

USD 438.80M

8.30 %

HEPA and EPA Filters

USD 26.01M

5.0 %

USD 59.30M

8.59 %

Gas-Phase Filtration

USD 98.84M

19.0 %

USD 284.63M

11.16 %

Housings / Monitoring

USD 88.43M

17.0 %

USD 189.75M

7.93 %

DC Exclusive: The 1 MW Filter Change-Out Ledger

DC Market Insights estimates a 2025 fleet-average replacement bill of about USD 3,600 per MW of air-handled IT load a year. The model combines airflow, filter-face count, filter prices and change frequency across recirculation, outside-air intake, make-up air, gas-phase media and electrical-room applications. This ledger explains why the installed base, rather than only the annual build cohort, drives long-term revenue.

Metric

2025 estimate

Replacement filter bill per air-handled MW

USD 3,600/year

First-fit bill per new air-handled MW

USD 11,000

Replacement share of market

78.3 %

Air-handled load

113.1 GW

Which Region Leads the Data Center Air Filtration Market?

North America leads with 39.0% of 2025 value, while the Middle East and Africa grows fastest at 12.13% a year as desert dust and harsh ambient conditions shorten filter life on new Gulf campuses. The United States is the largest country market, while India grows rapidly because dust and corrosive gases increase the need for fine and chemical media.

Indicator

2025 / Base

Outlook

Leading region

North America, 39.0% (USD 202.87 million)

Largest regional spending pool through the forecast

Fastest-growing region

Middle East and Africa, 12.13% CAGR

Dust-intensive Gulf campuses accelerate replacement demand

Largest country

United States, USD 189.34M in 2025

Remains the largest national market

How Could the 2035 Forecast Change?

The 2035 outcome depends on how much AI heat remains on the air side and how quickly filter prices and specification levels rise. The base case assumes liquid-cooled megawatts still send part of their heat to room air and replacement costs continue to increase.

Scenario

Assumption

2035 value

CAGR 2025-2035

Low

Lower air-side heat share and slower replacement inflation

USD 1.08B

7.55 %

Base

15% air-side heat share in mature liquid-cooled halls

USD 1.19B

8.59 %

High

Higher air-side heat share and wider MERV 13 / gas-phase adoption

USD 1.32B

9.78 %

Competitive Landscape and Recent Developments

The top five suppliers account for about half of 2025 value. Competition centers on particulate efficiency, pressure drop, molecular contamination control, replacement logistics and the ability to serve hyperscale customers across multiple regions.

Companies profiled include:

Camfil; AAF International (Daikin Industries); Parker Hannifin (Filtration Group and Purafil); Freudenberg Filtration Technologies; MANN+HUMMEL; Donaldson Company; Ahlstrom.

In September 2025, Camfil opened a HEPA and ULPA filter line at its Manesar plant in India.In November 2025, Parker Hannifin agreed to acquire Filtration Group, including Purafil, for USD 9.25 billion in cash.In November 2025, AAF International launched its AstroSorb molecular filter line in the United States.In March 2026, Camfil acquired Bioconservación (Bion) of Spain to expand molecular contamination control.In May 2026, Donaldson completed its acquisition of Facet Filtration and Camfil broke ground on a 14,400-square-metre expansion in Malaysia.In August 2026, Parker completed the Filtration Group acquisition, expected to add about USD 1.8 billion to fiscal 2027 sales.

Frequently Asked Questions

What is the size of the Data Center Air Filtration Market?

USD 520.20 million in 2025 and USD 589.74 million in 2026, projected to reach USD 1.19 billion by 2035 at an 8.59% CAGR.

Which filter type leads the market?

Fine filters, including bag and rigid box filters, with 38.0% of 2025 value.

Which segment grows fastest?

Gas-phase chemical filtration, at 11.16% a year through 2035.

Why is replacement spending so important?

Filters on the installed air-handled base are replaced repeatedly, giving replacement filters and media 78.3% of 2025 value.

Which region leads?

North America with 39.0% of 2025 value; the Middle East and Africa grows fastest at 12.13% a year.

Who are the leading suppliers?

Camfil, AAF International, Parker Hannifin, Freudenberg Filtration Technologies and MANN+HUMMEL are among the leading suppliers.

Methodology

DC Market Insights builds the market bottom-up from air-handled installed IT load, annual new capacity, filter faces per MW, replacement frequency, public filter price anchors and application mix. The model is checked against an all-air ceiling, supplier sales and a MERV 8 replacement floor before regional and segment splits are reconciled.

Download Sample Report – Data Center Air Filtration Market

Related Reports from DC Market Insights

 

Data Center Thermal Management MarketData Center Precision Air Conditioning MarketData Center Cooling MarketData Center Liquid Cooling MarketData Center Cooling Tower Market

DC Market Insights Data & Tools

Explore live datasets and decision tools used across DC Market Insights research:

Data Center Database 

Data Centers 

Data Centers Operators 

Global Data Center Capacity 

Deal Tracker 

Power Policy 

Data Center PUE Calculator 

Data Center Construction Pipeline 

Data Center Transaction Comps 

Data Center Site Risk 

Data Center Electricity Rates 

Data Center Footprint 

About DC Market Insights

DC Market Insights is a dedicated research and consulting firm that empowers data center leaders with actionable intelligence. We combine rigorous market research, advanced analytics and practical advisory support to help organizations make confident decisions in an increasingly complex digital infrastructure landscape. Our goal is to transform data into clarity, giving clients the ability to act decisively on strategy, investment and execution.

Contact Us

DC Market Insights

Tower C-1105, S 25, Akash Tower, Vishal Nagar, Pimple Nilakh, Haveli, Pune – 411027, India

Email: sales@dcmarketinsights.com 

United States: +1 628 262 7656

United Kingdom: +44 7453 598 606

Web: www.dcmarketinsights.com 

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/data-center-air-filtration-market-to-reach-usd-1-19-billion-by-2035-as-replacement-filters-and-gas-phase-media-drive-recurring-spend—dc-market-insights-302914605.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