About RIVANNA: Our Mission and World-First Imaging Technology
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 automates complex anatomical analysis at the point of care, enabling faster, more confident clinical decisions while reducing variability and expanding access to advanced capabilities. The first applications target significant market opportunities in regional anesthesia and fracture care.
RIVANNA’s AI-powered clinical decision-support platform is protected by a strong IP portfolio, with FDA-cleared devices and next-generation AI software on defined 510(k) pathways. The company is headquartered in Charlottesville, Virginia, and operates an FDA-registered, ISO 13485:2016-certified manufacturing facility.
Key Achievements in Medical Innovation
A track record of regulatory clearances, clinical validation, strategic partnerships, and foundational IP — from university lab to commercial-stage platform.
510(k) Clearance: Accuro XV Diagnostic Ultrasound System
FDA granted 510(k) clearance for the Accuro XV platform, authorizing commercial use for musculoskeletal imaging by trained healthcare professionals.
Read press releaseUVA Feasibility Study Published: Journal of Emergency Medicine
First peer-reviewed publication demonstrated non-physician operators acquired diagnostic-quality extremity images with just one hour of training. Over 90% of scans rated adequate for diagnostic interpretation.
Read press releaseMulti-Site Clinical Expansion: Accuro XV
Expanded the Accuro XV clinical program from two to eight academic medical centers nationwide, building the proprietary datasets required to train automated fracture detection algorithms.
Read press release100th Patent Filing: AI-Powered Pathology Detection System
Interconnected AI pipeline for automated pathology detection from volumetric ultrasound images, incorporating innovations in frame-, scan-, and subject-level pathology detection and decision support.
510(k) Clearance: Accuro 3S Diagnostic Ultrasound System & SpineNav-AI Software
FDA cleared the Accuro 3S platform and its AI-powered image processing software for spinal navigation.
Read press release510(k) Clearance: Accuro 3S Needle Guide Kit Consumables
Cleared consumables enable full procedural workflow on the Accuro 3S platform.
Read press releaseBARDA Partnership: Accuro XV CADe/X AI Module Development
Continued collaboration with BARDA to advance the AI-powered fracture detection module toward FDA submission.
Read press releaseMedTech Innovator 2025 Accelerator: Top 4% of 1,500 Global Applicants
Selected as one of 65 companies for the MTI accelerator. Named a finalist in the Early-Stage Grand Prize competition.
Read press releaseSpineNav3D Core Navigation Algorithm: US Patent Granted
Real-time detection and tracking of bone anatomy acoustic features in ultrasound, providing automated graphical feedback for probe positioning during procedures with integrated guidance measurements: the core algorithm behind SpineNav3D automated spine recognition.
6-DOF Magnetic Needle Tracking and Real-Time Visualization
Rotatable magnetic source element with a non-coaxial magnetic axis, combined with multiple magnetic sensors in the probe housing, enables computation of full 6-degree-of-freedom (6DOF) pose of the needle relative to the probe (overlaying trajectory indicators and tip position on live ultrasound images in real time).
Multi-site First-in-Human Study: Accuro XV Musculoskeletal Imaging
Initiated multi-site clinical evaluation of Accuro XV performance and efficacy in musculoskeletal imaging.
Read press releaseExclusive Patent License from Duke University
Licensed key patent to advance next-generation ultrasound-guided imaging technology.
Read press releaseHands-Free Transducer Mounting for Continuous Procedural Imaging
Apparatus and method for affixing an ultrasound transducer to a patient with maintained acoustic coupling during a procedure, freeing both clinician hands for needle insertion, instrument manipulation, or other tasks while continuous imaging is preserved.
AI-Synthesized Anatomy for Occluded Landmark Recovery
Machine learning model that generates synthetic anatomical structures and landmark indicators in ultrasound images where bone or soft tissue features are obscured or distorted by patient anatomy; a trained anatomical prior model fills missing image context with anatomically plausible reconstructions to support SpineNav3D navigation.
Multi-Gap Transducer Array for Compound Guided Intervention
Multi-element ultrasound probe with a physical gap between arrays creating overlapping acoustic imaging regions; the gap supports in-plane instrument insertion with dual-perspective real-time imaging, and volumetric/compound acquisition modes enhance anatomical visualization for guided procedures.
Constrained Scanning Mechanism for Reproducible Volumetric Acquisition
Coupling article and mechanism that constrains transducer motion along a predefined rigid or curved path during volumetric ultrasound acquisition, using a non-aqueous mobile phase and controlled translation/rotation geometry to ensure consistent scan geometry across repeated examinations.
First Clinical Cases: Accuro 3S
Successfully completed initial clinical cases demonstrating utility in real-world settings.
BARDA Partnership: Accuro XV Comprehensive MSK Diagnostics & FDA Submission
Follow-on collaboration with BARDA to support further development and FDA clearance application for Accuro XV.
Read press releaseTunable Polyurethane Acoustic Coupling Material
Polyurethane gel formulation enabling conformable, skin-adherent ultrasound coupling without compromising transmission quality.
Bone Surface Imaging with Active Needle Guidance
Integrated system combining 3D ultrasound bone surface imaging with a mechanical apparatus that sets a predetermined spatial relationship between probe and needle guide; a processor uses the 3D bone surface model to automatically detect the target therapy site and generate real-time alignment guidance overlays for needle delivery.
AI Neural-Network Target Detection and Guided Needle Delivery
Integrates an object tracker with a 3D ultrasound probe and a mechanical needle guide; a neural network automatically detects the target therapy site within a 3D bone surface model, determines the appropriate needle position and orientation, and provides real-time display overlays showing bone landmark locations, target alignment, and needle trajectory indicators.
BARDA Partnership: Accuro XV Platform for Rapid Triage of Blast-Related Injuries
Initial collaboration with BARDA to develop point-of-care triage capabilities on the Accuro XV platform.
Read press releaseFacility Expansion & True-View Product Launch
Purchased 10,000 sq ft facility for manufacturing, commercial, and R&D growth. Launched the True-View product line.
Read press releaseTri-anim Distribution Alliance
Formed U.S. distribution partnership with Tri-anim to expand Accuro reach across clinical channels.
Read press releaseRotatable Display Handheld Ultrasound Device: Platform Hardware IP
Handheld ultrasound imaging device with a display rotatable ≥30° relative to the housing, an actuator on the handgrip for image capture and settings control, and automatic image-flip logic that maintains consistent anatomical orientation regardless of probe rotation (enabling true one-handed procedural operation).
Accuro Second-Generation Launch
Launched second-generation Accuro with thoracic paramedian epidural guidance preset.
Read press releaseHarmonic BoneEnhance: Second-Generation Bone Contrast
Extracts fundamental and harmonic frequency components from ultrasound data to independently compute bone presence (fundamental signal) and tissue presence (harmonic shadow intensity), then combines them into a composite bone image. The harmonic-derived tissue channel significantly improves signal-to-noise ratio compared with first-generation BoneEnhance.
B.Braun Japan Distribution Alliance
Established international distribution partnership in Japan.
Multi-Angle Volumetric Bone Imaging: BoneVision
System for acquiring bone images from multiple probe positions and angles, then reconstructing three-dimensional anatomical bone structures with higher sensitivity and a larger field of view than single-probe acquisition: the technical basis of BoneVision extended imaging mode.
Accuro 510(k) Pediatric Imaging Clearance
FDA cleared Accuro for pediatric imaging applications.
Chinese CFDA Registration
Secured regulatory registration for the Chinese market.
BoneEnhance Multi-Frequency Reconstruction
Multi-probe, multi-angle compound imaging technique that synthesizes ultrasound acquisitions from multiple spatial positions to reconstruct bone surfaces from specular reflectors, achieving a 5–10× increase in bone-to-tissue contrast compared with conventional ultrasound.
BoneEnhance / SpineNav3D Cornerstone Family
Computes shadow intensity data from raw ultrasound signals to separately identify bone and tissue regions (BoneEnhance contrast), then registers a real-time 2D ultrasound image to a 3D spinal bone model to automatically locate anatomical landmarks such as the spinous midline and epidural depth (SpineNav3D). Both innovations are claimed within a single integrated family.
Read press releaseCore Bone Imaging Science Secured
Algorithm for ultrasound imaging of specular-reflecting targets (bone surfaces), reducing off-axis reflection artifacts and improving bone surface definition: the scientific foundation for all subsequent BoneEnhance claims.
Accuro CE Mark
Received European CE Mark certification, enabling commercial distribution in the EU.
First US Patent Issued to Rivanna Medical
System and method for locating anatomical target regions using handheld ultrasound, including an integrated marking mechanism and alignment indicators that allow clinicians to accurately mark skin-entry points for spinal needle procedures (all with the probe in contact and without repositioning).
Read press releaseAccuro FDA 510(k) Clearance & Product Launch
First FDA clearance and commercial launch of the Accuro platform.
Read press releaseFoundational IP: Multi-view, multi-angle ultrasound pathology detection
Filed core patents on bone-tissue separation, anatomy segmentation, and spatial registration techniques that anchor platform development.
RIVANNA is Founded
Founded by University of Virginia graduate students. First prototype built with a toaster oven, a trailer hitch, and a deer-spine phantom.
Pioneering Ultrasound Technology
RIVANNA began in 2010, founded by graduate students at the University of Virginia. Co-founder Will Mauldin initiated the company after taking a Darden School of Business course while pursuing his Ph.D. in Biomedical Engineering (BME). Will identified an opportunity to apply his expertise in medical ultrasound technologies to address the high failure rates associated with epidural and spinal anesthesia placement. He recruited fellow BME graduate student Kevin Owen, who had industrial product development experience, to help establish the company.
Without company facilities or funding, they performed early-stage development in Kevin’s home attic, assembling the first circuit boards in a toaster oven. Will created the first prototype ultrasound transducers using a trailer hitch and hot glue, testing it in a deer spine phantom with materials from a recent hunting trip. This initial prototype provided the basic concept and preliminary data that attracted RIVANNA’s first outside funding from the Wallace H. Coulter Foundation in collaboration with Dr. John Hossack’s laboratory at the University of Virginia. Private seed investment followed, allowing Will and Kevin to lease office space and hire the company’s first employees.
From these humble beginnings, RIVANNA’s growth was marked by continuous improvement in product technology and securing subsequent rounds of funding. This relentless pursuit of excellence led to a significant milestone in 2015, when the Accuro product obtained FDA clearance and began commercialization. This achievement not only validated the founders’ vision but also marked the beginning of a new chapter in RIVANNA’s journey.
Our Origin Story
With a toaster oven, a trailer hitch, and deer-spine phantom, the initial Accuro prototype was a functional ultrasound scanning system due to resourcefulness and shared vision and responsibility.
Join Us in Transforming Point-of-Care Diagnostics
We’re seeking strategic partners and investors who share our vision for AI-powered clinical decision-support platforms. Let’s discuss how RIVANNA fits your portfolio.