Connect with us

Technology

CAE to increase ownership stake in SIMCOM Aviation Training joint venture and extend exclusive Business Aviation training agreement with Flexjet and its affiliates.

Published

on

Further supporting Flexjet’s global pilot training needs to meet increasing pilot ranks 

MONTREAL, Nov. 4, 2024 /PRNewswire/ – (NYSE: CAE) (TSX: CAE) – CAE announced today that it will increase its ownership stake in its existing SIMCOM Aviation Training (SIMCOM) joint venture by purchasing a majority of SIMCOM shares from Volo Sicuro for USD $230 million, subject to customary adjustments, to be financed with CAE’s existing credit facility and cash on hand. As part of the transaction, Flexjet, LLC, a related party of Volo Sicuro, will retain a minority stake in SIMCOM following the closing, expected to take place in the coming days. 

Additionally, CAE and SIMCOM will each extend their respective exclusive business aviation training services agreement with Flexjet and its affiliates by 5 years. This results in a remaining exclusivity period of 15 years for both agreements.

This significant organic investment will further solidify CAE’s presence in its core business aviation training market, increase recurring revenue streams, and reinforce its commitment to delivering world-class training solutions in business aviation. Its long-term exclusive training agreement with one of the world’s leading luxury private jet companies gives CAE even greater exposure to the rapidly growing fractional jet and charter aviation market. CAE expects this investment to be accretive to earnings and free cash flow in the first full-year post transaction.

“We are delighted to increase our investment in this core area and achieve majority ownership of SIMCOM to strengthen our position in the business aviation market, as well as extend our long-standing partnership with Flexjet, one of the leading and fastest growing private jet companies,” said Alexandre Prévost, Division President, Business Aviation. “This highlights our commitment to continuing to drive innovation and provide industry-leading technology to better serve our business aviation customers.”

“CAE has been a great partner over the years, consistently providing high-quality training and delivering a superior customer experience to all of our pilots,” said Flexjet CEO Mike Silvestro. “With this agreement, Flexjet’s 1,400+ pilots will continue to have access to state-of the-art facilities and experience world-class pilot training, enabling us to further enhance our pilots’ quality of life, both on the road, and during a pilot’s recurrent training. As demand for highly experienced, highly skilled pilots continues to rise, best-in-class training is essential to maintaining Flexjet’s unmatched safety standards. We look forward to our continued relationship and collaboration with CAE and SIMCOM long into the future.”

SIMCOM currently provides pilot training across multiple business aviation aircraft platforms, leveraging CAE’s innovative suite of training equipment, including CAE 7000XR Series full-flight simulators (FFSs) and CAE 400XR Series flight training devices (FTDs). SIMCOM operates four training centres in the United States, including its most recent state-of-the-art facility in Lake Nona, Florida.

About CAE

At CAE, we equip people in critical roles with the expertise and solutions to create a safer world. As a technology company, we digitalize the physical world, deploying software-based simulation training and critical operations support solutions. Above all else, we empower pilots, cabin crew, maintenance technicians, airlines, business aviation operators, and defence and security forces to perform at their best every day and when the stakes are the highest. Around the globe, we’re everywhere customers need us to be with approximately 13,000 employees in more than 240 sites and training locations in over 40 countries. CAE represents more than 75 years of industry firsts—the highest-fidelity flight and mission simulators as well as training programs powered by digital technologies. We embed sustainability in everything we do. Today and tomorrow, we’ll make sure our customers are ready for the moments that matter.

Read our FY24 Global Annual Activity and Sustainability Report.

Follow us on Twitter: @CAE_Inc
Facebook: www.facebook.com/cae.inc
LinkedIn: www.linkedin.com/company/cae
Hashtags: #CAE; #CAEpilot

About SIMCOM

A privately-owned, comprehensive learning institution, SIMCOM utilizes realistic simulator-based training to provide advanced aviation training services to professional pilots, owner-operators, Part 135 operators and maintenance personnel operating in general aviation, regional, military, government and cargo operations around the world.  SIMCOM currently operates 40+ simulators and flight training devices representative of a wide range of jet, turboprop and piston powered aircraft. The company is headquartered in Orlando, Florida.  www.simulator.com

About Flexjet

Flexjet, Inc., a global leader in private aviation, first entered the fractional jet ownership market in 1995 and is about to celebrate its 30th anniversary. Flexjet offers fractional jet ownership and leasing and is the first in the world to be recognized as achieving the Air Charter Safety Foundation’s Industry Audit Standard, is the first and only company to be honored with 25 FAA Diamond Awards for Excellence, upholds an ARG/US Platinum Safety Rating, a 4AIR Bronze Sustainable Rating and is certified at Stage 2 with IS-BAO. Red Label by Flexjet, a market differentiator, which features an ultra-modern fleet, flight crews dedicated to a single aircraft and the LXi Cabin Collection of interiors. To date there are nearly 50 different interior designs across its fleet, which includes the Embraer Phenom 300 and Praetor 500, Bombardier Challenger 350/3500, the Gulfstream G450 and G650. Flexjet’s European fleet includes the Embraer Praetor 600 and the Gulfstream G650. Flexjet’s helicopter division sells fractional, lease and on-demand charter access to its fleet of owned, operated and maintained Sikorsky S-76 helicopters which boast 55,000 hours of safe flying certified by Wyvern and ARG/US and serving locations throughout the northeastern United States, United Kingdom and Florida. Flexjet is a member of the Directional Aviation family of companies. For more details on innovative programs and flexible offerings, visit www.flexjet.com or follow us on Instagram @FlexjetInc.

Caution concerning forward-looking statements

This press release includes forward-looking statements about the increase by CAE of its ownership stake in the SIMCOM joint venture (the Transaction), the anticipated benefits and expected impacts therefrom on CAE’s strategic and operational plans and financial results, including with respect to the Transaction’s anticipated impact on CAE’s earnings and free cash flow, the expected terms, conditions and completion of the Transaction, including the extension of exclusivity periods under any existing business aviation training services agreements, the timing for completion and the anticipated financing sources for the Transaction, as well as CAE’s activities, events and developments that it expects to or anticipates may occur in the future including, for example, statements about CAE’s vision, strategies, market trends and outlook, future revenues, earnings, cash flow growth, profit trends, growth capital spending, expansions and new initiatives, including initiatives that pertain to environmental, social and governance (ESG) matters, financial obligations, available liquidities, expected sales, general economic and political outlook, inflation trends, prospects and trends of an industry, expected annual recurring cost savings from operational excellence programs, our management of the supply chain, estimated addressable markets, demands for CAE’s products and services, our access to capital resources, our financial position, the expected accretion in various financial metrics, the expected capital returns to shareholders, our business outlook, business opportunities, objectives, development, plans, growth strategies and other strategic priorities, and our competitive and leadership position in our markets, the expansion of our market shares, CAE’s ability and preparedness to respond to demand for new technologies, the sustainability of our operations, and other statements that are not historical facts.

Since forward-looking statements and information relate to future events or future performance and reflect current expectations or beliefs regarding future events, they are typically identified by words such as “anticipate”, “believe”, “could”, “estimate”, “expect”, “intend”, “likely”, “may”, “plan”, “seek”, “should”, “will”, “strategy”, “future” or the negative thereof or other variations thereon suggesting future outcomes or statements regarding an outlook. All such statements constitute “forward-looking statements” within the meaning of applicable Canadian securities legislation and “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. By their nature, forward looking statements require CAE to make assumptions and are subject to inherent risks and uncertainties associated with CAE’s business which may cause actual results in future periods to differ materially from results indicated in forward-looking statements. While these statements are based on management’s expectations and assumptions regarding historical trends, current conditions and expected future developments, as well as other factors that CAE believes are reasonable and appropriate in the circumstances, readers are cautioned not to place undue reliance on these forward-looking statements as there is a risk that they may not be accurate. The forward-looking statements contained in this press release describe our expectations as of November 4, 2024 and, accordingly, are subject to change after such date.

Important risks that could cause such differences include risks relating to the Transaction, such as all or part of the intended benefits therefrom not being realized, failure to satisfy the conditions to the completion of the Transaction or delay in completing it and uncertainty regarding the length of time required to complete the Transaction, the impact of the announcement of the Transaction on CAE’s relationships with third parties, including commercial counterparties, suppliers, employees and competitors, strategic relationships, operating results and businesses generally, the occurrence of an event which would allow the parties to terminate their obligations, commitments and undertakings pursuant to the Transaction documentation, changes in the terms of the Transaction, the failure by the parties to fulfill their obligations, commitments and undertakings pursuant to the Transaction documentation. If the proposed Transaction is not completed for any reason, there is a risk that the announcement of such Transaction and the dedication of substantial resources of CAE to the completion thereof could have a negative impact on our operating results and business generally, and could have a material adverse effect on our current and future operations, financial condition and prospects. In addition, failure to complete the proposed Transaction for any reason could materially negatively impact the market price of our securities.

Additional risks that could cause such differences include, but are not limited to, strategic risks, such as geopolitical uncertainty, global economic conditions, competitive business environment, original equipment manufacturer (OEM) leverage and encroachment, inflation, international scope of CAE’s business, level and timing of defence spending, constraints within the civil aviation industry, CAE’s ability to penetrate new markets, research and development activities, evolving standards and technology innovation and disruption, length of sales cycle, business development and awarding of new contracts, strategic partnerships and long-term contracts, risk that CAE cannot assure investors that it will effectively manage its growth, estimates of market opportunity and competing priorities; operational risks, such as supply chain disruptions, program management and execution, mergers and acquisitions, business continuity, subcontractors, fixed price and long-term supply contracts, CAE’s continued reliance on certain parties and information, and health and safety; cybersecurity risks; talent risks, such as recruitment, development and retention, ability to attract, recruit and retain key personnel and management, corporate culture and labour relations; financial risks, such as availability of capital, customer credit risk, foreign exchange, effectiveness of internal controls over financial reporting, liquidity risk, interest rate volatility, returns to shareholders, shareholder activism, estimates used in accounting, impairment risk, pension plan funding, indebtedness, acquisition and integration costs, sales of additional common shares, market price and volatility of CAE’s common shares, seasonality, taxation matters and adjusted backlog; legal and regulatory risks, such as data rights and governance, U.S. foreign ownership, control or influence mitigation measures, compliance with laws and regulations, insurance coverage potential gaps, product-related liabilities, environmental laws and regulations, government audits and investigations, protection of CAE’s intellectual property and brand, third-party intellectual property, foreign private issuer status, and enforceability of civil liabilities against CAE’s directors and officers; ESG risks, such as extreme climate events and the impact of natural or other disasters (including effects of climate change) and more acute scrutiny and perception gaps regarding ESG matters; reputational risks; and technological risks, such as information technology and reliance on third-party providers for information technology systems and infrastructure management. The foregoing list is not exhaustive and other unknown or unpredictable factors could also have a material adverse effect on the performance or results of CAE. Additionally, differences could arise because of events announced or completed after the date of this press release. More information about the risks and uncertainties affecting CAE’s business can be found in the Management’s Discussion & Analysis for the year ended March 31, 2024 and the Management’s Discussion & Analysis for the quarter ended June 30, 2024. Accordingly, readers are cautioned that any of the disclosed risks could have a material adverse effect on CAE’s forward-looking statements. Readers are also cautioned that the risks described above and elsewhere in this press release, and in the documents referenced herein, are not necessarily the only ones CAE faces; additional risks and uncertainties that are presently unknown to CAE or that CAE may currently deem immaterial may adversely affect CAE’s business. 

Except as required by law, CAE disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise. The forward-looking information and statements contained in this press release are expressly qualified by this cautionary statement. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based on information available to us as of the date of this press release. While we believe that information provides a reasonable basis for these statements, that information may be limited or incomplete. Our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely on these statements.

Material Assumptions

The forward-looking statements set out in this press release are based on certain assumptions including, without limitation: the satisfaction of all closing conditions of the Transaction, our ability to otherwise complete the Transaction within anticipated time periods and at expected cost levels, management’s estimates and expectations in relation to future economic and business conditions and other factors in relation to the Transaction, the realization of the expected strategic, financial and other benefits of the Transaction in the timeframe anticipated, fulfillment by the other parties of their respective obligations, commitments and undertakings pursuant to the Transaction documentation, prevailing market conditions, and no material financial, operational or competitive consequences of changes in regulations affecting CAE’s business. For additional information, including with respect to other assumptions underlying the forward-looking statements made in this press release, refer to the applicable reportable segment in the Management’s Discussion & Analysis for the year ended March 31, 2024 and the Management’s Discussion & Analysis for the quarter ended June 30, 2024. Accordingly, the assumptions outlined in this press release, and in the documents referenced herein, and, consequently, the forward-looking statements based on such assumptions, may turn out to be inaccurate.

SIMCOM Contacts

CAE Contacts:
General Media:
Samantha Golinski, Vice President, Public Affairs & Global Communications
+1-438-805-5856, samantha.golinski@cae.com

Investor Relations:
Andrew Arnovitz, Senior Vice President, Investor Relations and Enterprise Risk Management,
+1-514-734-5760, andrew.arnovitz@cae.com

Flexjet Contact:
Susan Ruiz Patton, Flexjet Head of External Communications,
216-333-9526 (mobile), Susan.Ruiz.Patton@flexjet.com

View original content:https://www.prnewswire.com/news-releases/cae-to-increase-ownership-stake-in-simcom-aviation-training-joint-venture-and-extend-exclusive-business-aviation-training-agreement-with-flexjet-and-its-affiliates-302295924.html

SOURCE CAE Inc.

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