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

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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

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Cboe Clear U.S. Receives SEC Approval to Expand Clearing Capabilities

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SEC registration enables Cboe Clear U.S. to clear binary securities options alongside futures, positioning it to support innovation across the market

CHICAGO, Oct. 23, 2026 /PRNewswire/ — Cboe Global Markets, Inc. (Cboe: CBOE), a leading global markets operator and pioneer in equity and index derivatives, today announced that Cboe Clear U.S., LLC (CCUS) has received temporary registration from the U.S. Securities and Exchange Commission (SEC) to operate as a Covered Clearing Agency.

The registration expands CCUS’s clearing capabilities beyond its existing authorities as a Commodity Futures Trading Commission (CFTC)-registered Derivatives Clearing Organization (DCO) to clear securities products in addition to futures and swaps products. Together with recent enhancements to its regulatory framework and product scope, the milestone positions CCUS to support innovation and emerging opportunities across a broad range of assets and markets.

CCUS will initially use its SEC registration to clear Cboe’s binary securities options tied to specified corporate key performance indicators (KPIs), which are planned to list on Cboe Options Exchange and be available on Robinhood in the fourth-quarter 2026. CCUS also recently received CFTC approval to clear margined futures broadly and continues to clear digital asset derivatives under its DCO designation.

“Clearing plays a critical role in bringing innovation to market,” said Dale Michaels, Head of Cboe Clear U.S. “These expanded capabilities position Cboe Clear U.S. to become an innovation lane to support new products and meet evolving customer needs, while maintaining the rigorous risk management standards that are fundamental to our business.”

These efforts complement Cboe’s longstanding partnership with The Options Clearing Corporation (OCC)® and Cboe’s continued commitment to supporting the established clearing infrastructure for traditional equity options.

The development builds on the growth of Cboe’s established European clearing business, where Cboe Clear Europe has become the leading pan-European equities central counterparty, while expanding into new services such as securities financing transaction clearing. Together, these advances demonstrate Cboe’s ability to extend its clearing capabilities across markets and asset classes.

To support its own future growth, CCUS has strengthened its infrastructure over the past year, including electing in June to become a Subpart C DCO. In doing so, CCUS is voluntarily adopting the enhanced standards the CFTC applies to systemically important DCOs for financial resources, risk management and operational resilience, aligning with those applied to leading global clearing organizations.

About Cboe Global Markets

Cboe Global Markets (Cboe: CBOE) is a leading global markets operator with a long history of innovation in equity and index derivatives. Since launching the world’s first listed options exchange in 1973, Cboe has pioneered landmark products, including the introduction of S&P 500® index options and the creation of the VIX® Index, the world’s leading gauge of market volatility, reshaping how investors manage risk and access opportunity. Today, Cboe operates derivatives, equities, and FX markets, providing trading, clearing, and investment solutions for customers worldwide. To learn more, visit www.cboe.com.

Cboe Media Contacts

 

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Cboe®, Cboe Global Markets®, and VIX ® are registered trademarks or service marks of Cboe Exchange, Inc and S&P 500® is a registered trademark of Standard & Poor’s Financial Services LLC. All other trademarks and service marks are the property of their respective owners. 

Cautionary Statements Regarding Forward-Looking Information

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve a number of risks and uncertainties. You can identify these statements by forward-looking words such as “may,” “might,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” and the negative of these terms and other comparable terminology. All statements that reflect our expectations, assumptions or projections about the future other than statements of historical fact are forward-looking statements. These forward-looking statements, which are subject to known and unknown risks, uncertainties and assumptions about us, may include projections of our future financial performance based on our growth strategies and anticipated trends in our business. These statements are only predictions based on our current expectations and projections about future events. There are important factors that could cause our actual results, level of activity, performance or achievements to differ materially from those expressed or implied by the forward-looking statements.

We operate in a very competitive and rapidly changing environment. New risks and uncertainties emerge from time to time, and it is not possible to predict all risks and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.

Some factors that could cause actual results to differ include: the loss of our right to exclusively list and trade certain index options and futures products; economic, political and market conditions; compliance with legal and regulatory obligations; price and new products and services competition and consolidation in our industry; decreases in trading or clearing volumes, market data fees or a shift in the mix of products traded on our exchanges; legislative or regulatory changes or changes in tax regimes; our ability to protect our systems and communication networks from security vulnerabilities and breaches; our ability to attract and retain skilled management and other personnel; increasing competition by foreign and domestic entities; our business and operational dependence on and exposure to risk from third parties; factors that impact the quality and integrity of our and other applicable indices; our ability to manage our global operations, growth, and strategic acquisitions, wind downs, divestitures, or alliances effectively; increases in the cost of the products and services we use; our ability to operate our business without violating the intellectual property rights of others and the costs associated with protecting our intellectual property rights; our ability to minimize the risks, including our credit, liquidity, market, investment, counterparty, and default risks, associated with operating our  clearinghouses; our ability to accommodate trading and clearing volume and transaction traffic, including significant increases, without failure or degradation of performance of our systems; misconduct by those who use our markets or our products or for whom we clear transactions; challenges to our use of open source software code; our ability to meet our compliance obligations, including managing our business interests and our regulatory responsibilities; the loss of key customers or a significant reduction in trading or clearing volumes by key customers; damage to our reputation; the ability of our compliance and risk management methods to effectively monitor and manage our risks; restrictions imposed by our debt obligations and our ability to make payments on or refinance our debt obligations; our ability to maintain an investment grade credit rating; impairment of our goodwill, long-lived assets, investments or intangible assets; the accuracy of our estimates and expectations; and litigation risks and other liabilities. More detailed information about factors that may affect our actual results to differ may be found in our filings with the SEC, including in our Annual Report on Form 10-K for the year ended December 31, 2025 and other filings made from time to time with the SEC.

We do not undertake, and we expressly disclaim, any duty to update any forward-looking statement whether as a result of new information, future events or otherwise, except as required by law. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.

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SOURCE Cboe Global Markets, Inc.

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Hears Everything, Uploads Nothing: VoxNexus Launches Android’s First Low-Power On-Device Always-On Voice Artificial Intelligence (AI)

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VoxNexus’ new on-device ambient listening solution runs for 12 hours on 2.49% of a phone’s battery and never sends audio to the cloud

MADRID, Oct. 23, 2026 /PRNewswire/ — VoxNexus (www.VoxNexus.ai) released VoxEdge, an on-device voice stack that brings speech recognition, translation and speech synthesis to affordable Android devices, entirely offline. VoxEdge supports speech recognition in 36 languages, translation in 103 languages, and speech synthesis in 45 languages—all running with no connection, no data bundle, and no cloud token bills.

AI should work for everyone, not just for speakers of a handful of mainstream languages. Yet across much of Africa, voice AI has been held back by scarce training data and the lack of targeted fine-tuning. Everyday speech also includes code-switching and dialect variation, while cloud-based inference costs can make deployment at scale expensive. 

VoxNexus’s solutions run entirely on device, and every query is free once the model is installed on the device. Its speech recognition model has as few as 65 million parameters and achieves a lower word error rate than open-source models nearly ten times its size.

“Under-resource languages aren’t small languages. Hundreds of millions of people speak them. Until now, AI models just haven’t learned them yet,” said Charles Shi, CEO of VoxNexus.

VoxNexus also launched VoxSense, an on-device ambient listening solution that uses only 162 mAh for 12 hours of continuous listening, around 2.5% of a 6,500 mAh phone battery. By keeping all processing on device, VoxSense makes always-on listening practical without draining the battery and without sending any audio to the cloud. Developers and device makers can easily integrate it through a license and a simple SDK. Developers can request a free trial here: www.VoxNexus.ai.

VoxSense and VoxEdge were unveiled at the MediaTek Dimensity 9600 launch in Madrid on October 19.

Distributed by APO Group on behalf of VoxNexus AI. 

About VoxNexus:
VoxNexus builds AI that hears and speaks — for everyone, everywhere, all the time. Its audio intelligence runs entirely on-device, delivering low latency, built-in privacy, and zero token cost across any device with a chip. VoxNexus is headquartered in Singapore. Website: www.VoxNexus.ai. Contact: public@voxnexus.ai  

VoxNexus demonstrates live on-device speech recognition at the MediaTek Dimensity 9600 launch in Madrid on Oct. 19, 2026. Spanish and English conversations were transcribed in real time on the phone, with no cloud connection. (Photo: VoxNexus) 

Speaks Your Language, No Internet Needed: VoxNexus Brings On-Device Voice Artificial Intelligence (AI) in 100+ Languages to Affordable Android Devices

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SOURCE VoxNexus AI

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team.blue extends €1.1 billion of its Term Loan B to 2032 in the largest software Euro term loan issuance in the last 12 months

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GHENT, Belgium, Oct. 23, 2026 /PRNewswire/ — team.blue, a leading pan-European provider of digital solutions for small and medium-sized businesses (SMBs) backed by Hg, CPP Investments and Sofina, today announces the successful pricing of an amendment and maturity extension for €1.1 billion of its existing €1.35 billion Term Loan B. The transaction priced on 22 October 2026, with the refinanced tranche extended from September 2029 to July 2032, reinforcing the Company’s prudent capital structure approach.

Strong demand from a broad group of institutional investors enabled team.blue to upsize the transaction twice in-market, taking the final deal size to €1.1 billion from a minimum initial launch size of €500 million, despite recent credit market volatility. Pro forma for the transaction, c.90% of team.blue’s term debt now matures in 2032.

The transaction comes at a time of significant momentum for team.blue, with continued double-digit revenue growth and strong cash generation supporting its deleveraging trajectory. Its products help Europe’s SMBs get online, get customers, get paid and stay compliant, and AI-enabled products are increasingly driving new customer growth. team.blue continues to innovate across its portfolio, from smarter tools within its brands to secure European cloud hosting built for customers’ growing AI workloads. Its category-leading SaaS brands are also integrating with leading AI assistants, bringing team.blue’s products to customers wherever they work.

Transaction highlights

The largest software Euro term loan issuance in the last 12 months€1.1 billion Term Loan B, borrowed by team.blue Finco S.à r.l., maturing July 2032Priced at E + 425bps with a 0% floor and an OID of 98.5Upsized twice from an initial €500 million, reflecting a heavily oversubscribed order bookCorporate and facility ratings of B3 (Moody’s) and B (S&P), both with stable outlooksBofA acted as Global Coordinator and Left Lead Physical Bookrunner, alongside Barclays. ABN AMRO, BNP Paribas, Citi, ING and J.P. Morgan acted as Bookrunners

Jonathan Thackray, Chief Financial Officer of team.blue, said:
“We set out to extend €500 million of our Term Loan B, and the depth of support from our institutional investor base allowed us to go much further. This reflects confidence in team.blue’s highly recurring, cash-generative model and our position as a leading digital partner for Europe’s SMBs. It gives us the flexibility to keep innovating and investing in the digital and AI-enabled tools our customers rely on.”

About team.blue
team.blue is the pan-European digital partner for small and medium businesses, serving more than 3.5 million customers in 24 countries. From web hosting, domains, email and cloud and AI infrastructure to e-commerce, engagement, payments and compliance tools, team.blue helps SMBs get online, get customers, get paid and stay compliant. Supported by more than 4,000 employees, team.blue’s vision is to make online business success simpler, with artificial intelligence at every step. 

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