RIVANNA has won FDA 510(k) clearance for BoneEnhance, a machine-learning layer that finds bone in 3D ultrasound scans and marks it on the image for the clinician performing the exam. The Charlottesville, Virginia company announced the clearance on 22 October 2026, calling it the first machine-learning software cleared on its Accuro XV platform — a point-of-care ultrasound system aimed at spinal procedure guidance and musculoskeletal imaging without X-ray radiation.
BoneEnhance in four figures
Figures from RIVANNA's 22 October 2026 clearance announcement.
What a label on a bone is worth in a spinal block
Neuraxial procedures — epidurals and spinal blocks — are normally guided by feeling for bony landmarks through the skin, a technique multiple clinical reviews describe as unreliable, especially in patients with a higher body-mass index. RIVANNA's pitch is a 3D ultrasound sweep that shows the vertebral anatomy underneath instead of asking the clinician to feel for it. BoneEnhance is the software that reads that sweep: it finds bone and soft tissue in the 3D volume and overlays color-coded labels on the 2D image the clinician is actually looking at, rather than leaving interpretation entirely to the operator's eye.
“BoneEnhance is where the stack begins to close that gap for musculoskeletal care: automated volumetric acquisition, now paired with cleared software-assisted review.” Will Mauldin, PhD, Co-founder and Chief Executive Officer, RIVANNA — 22 October 2026 announcement
Three things that separate BoneEnhance from reading the scan cold
A dedicated validation set
233 volumetric datasets, 69,900 images, 173 subjects, labeled independently by three board-certified radiologists — a larger, more structured test than most cleared imaging add-ons publish at clearance.
Built on an existing cleared platform
BoneEnhance is a software-only 510(k) layered on Accuro XV's own April 2026 clearance (K254021), not a new hardware submission — the kind of incremental filing FDA's traditional 510(k) pathway is built for.
No ionizing radiation
Ultrasound avoids the X-ray dose that fluoroscopy-guided spinal procedures require, at the cost of needing a trained hand to acquire a usable 3D sweep in the first place — the gap BoneEnhance's labeling is meant to narrow.
A crowded, early field for AI-guided needle placement
RIVANNA is not alone in trying to make ultrasound-guided procedures less dependent on an expert eye. SmartAlpha's Nerveblox, FDA-cleared in August 2025, highlights roughly 50 anatomical structures in real time for regional nerve blocks and is already approved in the EU, UK and Australia. Intelligent Ultrasound's ScanNav Anatomy Peripheral Nerve Block reached the U.S. market earlier still, via FDA's De Novo pathway, with a similar anatomy-highlighting approach for peripheral nerve blocks. Neither targets spinal bone segmentation specifically the way BoneEnhance does, and a separate academic system out of Singapore (uSINE, not commercially available or FDA cleared) has reported a 92% first-attempt success rate for automated spinal-landmark identification in a 100-patient study — a research result, not a cleared product, but a sign of where the field is headed.
BoneEnhance against AI-assisted procedure guidance
| Product | Target procedure | Status | Modality |
|---|---|---|---|
| BoneEnhance (RIVANNA) | Spinal/neuraxial & musculoskeletal imaging | FDA cleared, Oct 2026 | 3D ultrasound + ML bone segmentation |
| Nerveblox (SmartAlpha) | Regional nerve blocks | FDA cleared, Aug 2025 | Real-time anatomy highlighting |
| ScanNav Anatomy Peripheral Nerve Block (Intelligent Ultrasound) | Peripheral nerve blocks | FDA De Novo, cleared | Real-time anatomy highlighting |
| uSINE (academic, KKH/NUS Singapore) | Spinal anesthesia landmarks | Research only, not FDA cleared | Automated landmark identification |
From each organization's own publications and FDA clearance records; not a clinical comparison. uSINE is a research system, not a commercially available or FDA-cleared product.
A ten-fold spread in what point-of-care ultrasound is worth
Published estimates for the point-of-care ultrasound market disagree sharply depending on how narrowly each research firm draws the category: Fortune Business Insights puts 2026 at roughly $1.7 billion, 360iResearch at roughly $4.4 billion, and Global Market Insights at roughly $4.2 billion for the prior year — a spread wide enough that the publisher matters as much as the number. BoneEnhance sits inside a narrower, faster-growing slice: AI software layered onto existing imaging hardware, where Meticulous Research estimates the broader AI-in-medical-imaging market at $2.37 billion in 2026, growing at better than 25% a year.
AI-assisted medical imaging, by one widely cited estimate
$2.37B → $22.8B
AI in medical imaging, 2026 to 2036, as forecast by Meticulous Research; point-of-care ultrasound hardware shown separately for scale.
Sources: Meticulous Research, AI in Medical Imaging Market report, 2026 · 360iResearch, Point-of-Care Ultrasound Devices Market report, 2026
Regulatory News outlook
We expect software-only add-ons like BoneEnhance to grow faster than point-of-care ultrasound hardware itself, since they monetize scanners already in the field rather than depending on new hardware sales.
How we got here: Meticulous Research's 25.4% compound annual growth rate for AI medical imaging, applied to its own $2.37 billion 2026 base, implies the software layer alone roughly doubles every three years — a faster published rate than any point-of-care ultrasound hardware forecast we found (7–16% CAGR across three publishers).
Sixteen years from a UVA lab bench to a software clearance
RIVANNA's road to BoneEnhance
- 2010
RIVANNA founded
Founded by University of Virginia researchers, including Will Mauldin, to commercialize point-of-care ultrasound research.
- 2012
First seed funding
A $50,000 CIT GAP Funds seed round, followed over the next decade by a mix of grants and government contracts, including from BARDA, that the company says total more than $90 million.
- April 2026
Accuro XV cleared
FDA clears the Accuro XV base platform (K254021), a portable 3D ultrasound system for musculoskeletal imaging.
- 22 October 2026
BoneEnhance cleared
FDA clears BoneEnhance, a machine-learning layer that segments and labels bone on top of Accuro XV, validated against 233 independently labeled scans.
- Ahead
A published K-number
BoneEnhance's own 510(k) number has not yet appeared in FDA's public database; RIVANNA's clearance announcement is the only public record so far.
What BoneEnhance's own numbers don't yet answer
RIVANNA's reported 95.1%-to-100% accuracy range comes entirely from the company's own clearance announcement; we could not locate a peer-reviewed publication or conference abstract presenting the same 233-scan, 173-subject dataset, and outlets covering the clearance describe the underlying multi-site study's size inconsistently — as five, eight or ten sites, depending on the outlet. None of that contradicts the headline accuracy figures, but a reader comparing BoneEnhance to a peer-reviewed device should know the validation lives in a press release, not a journal.
- No published K-number yet: BoneEnhance's 510(k) clearance had not appeared in FDA's public database at the time of this clearance announcement; the base Accuro XV platform's own clearance (K254021) is on the record.
- Funding is mostly non-dilutive: RIVANNA says it has secured over $90 million since 2010, dominated by government contracts (including from BARDA) rather than priced venture rounds — a different capital structure than most device startups its age.
- A crowded adjacent field: at least two other FDA-cleared AI ultrasound-guidance products already address related but distinct procedures (nerve blocks), and an academic group has published a competing approach to the same spinal-landmark problem.
- No clinical outcomes data yet: accuracy against radiologist labels is not the same claim as improved first-attempt success or reduced complication rates in actual neuraxial procedures; RIVANNA has not published outcomes data for BoneEnhance specifically.
Sources & further reading
- RIVANNA, “FDA Grants 510(k) Clearance for BoneEnhance, the First Machine Learning Layer on RIVANNA's Accuro XV Platform,” press release, 22 October 2026. prnewswire.com
- AuntMinnie, “RIVANNA gets FDA clearance for BoneEnhance ultrasound software,” 22 October 2026. auntminnie.com
- Diagnostic Imaging, “FDA Machine Learning Module for Emerging Musculoskeletal Ultrasound Platform,” 22 October 2026. diagnosticimaging.com
- U.S. Food and Drug Administration, 510(k) premarket notification K254021 (RIVANNA Accuro XV). accessdata.fda.gov
- RIVANNA, “RIVANNA's Accuro XV Demonstrates Feasibility of Musculoskeletal Imaging by Non-physician Users With Minimal Training.” rivannamedical.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA clear for RIVANNA?
BoneEnhance, a machine-learning software layer for RIVANNA's Accuro XV ultrasound platform that segments bone and surrounding tissue in 3D ultrasound volumes and labels it on 2D images, for spinal (neuraxial) procedure guidance and musculoskeletal imaging. FDA cleared it 22 October 2026; the clearance's 510(k) number was not yet publicly listed at publication.
What is the Accuro XV?
A portable, point-of-care 3D ultrasound system RIVANNA markets for musculoskeletal and spinal imaging, cleared by FDA in April 2026 (decision date; announced in May). BoneEnhance is a software add-on cleared separately on top of that platform.
How accurate is BoneEnhance?
RIVANNA reports a per-volume label accuracy of 95.1% to 100% against an independent test set of 233 volumetric scans (69,900 images) from 173 subjects, reference-labeled by three board-certified radiologists. That figure comes from the company's own clearance announcement; it has not appeared in a peer-reviewed publication that we could locate.
Is RIVANNA a public company?
No. RIVANNA is privately held, founded in 2010 by University of Virginia researchers including CEO Will Mauldin. It has disclosed over $90 million in funding, much of it non-dilutive government contracts, including from BARDA.
