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.
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 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.
UVA 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.
BARDA 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 releaseMulti-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 releaseFirst 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 releaseBARDA 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 releaseAccuro Second-Generation Launch
Launched second-generation Accuro with thoracic paramedian epidural guidance preset.
Read press releaseB.Braun Japan Distribution Alliance
Established international distribution partnership in Japan.
Accuro 510(k) Pediatric Imaging Clearance
FDA cleared Accuro for pediatric imaging applications.
Chinese CFDA Registration
Secured regulatory registration for the Chinese market.
Accuro CE Mark
Received European CE Mark certification, enabling commercial distribution in the EU.
Accuro FDA 510(k) Clearance & Product Launch
First FDA clearance and commercial launch of the Accuro platform.
Read press releaseFoundational IP — Ultrasound-Based Fracture Detection
Initial development of core fracture detection technology that would become the Accuro XV platform.
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.