Accuro 3S

by Rivanna Medical  · Based in United States → — Precision in Action
Anesthesiology Interventional Radiology Physical Medicine & Rehab

Starts at $5,999 usd (for accuro product line)
Regulatory Status Disclosed

Overview

Accuro 3S by Rivanna Medical is an AI-enabled diagnostic ultrasound system designed for neuraxial anesthesia and spinal interventions. It features a proprietary Dual-Array™ convex probe and integrated SpineNav-AI™ image processing software. The system provides clinicians with continuous, in-plane needle tracking and automated identification of key anatomical landmarks, such as the spinal midline, interlaminar space, and epidural depth. This technology aims to streamline complex spinal and epidural procedures, offering practical solutions to long-standing challenges in neuraxial anesthesia, including improving first-attempt success rates, particularly in patients with challenging anatomy. The Accuro 3S supports standard B-mode imaging and is presented as a portable, point-of-care ultrasound system with a touchscreen interface and healthcare IT connectivity to implement DICOM-based patient and image archival workflows. A novel patient drape is also part of the system, enhancing probe stability and addressing the ‘three-hands’ problem during procedures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-enabled software for continuous, in-plane needle tracking
  • Proprietary Dual-Arrayu2122 convex probe design
  • Automated identification of key anatomical landmarks (SpineNav-AIu2122)
  • Streamlines complex spinal and epidural procedures
  • Novel patient drape for enhanced probe stability and single-operator efficiency
  • Portable, point-of-care ultrasound system
  • Touchscreen interface
  • Healthcare IT connectivity for DICOM-based patient and image archival workflows
  • BoneEnhanceu00ae Multi-Frequency Image Reconstruction for enhanced bone-to-tissue contrast
  • Midline and Cross Hair indicators for ideal insertion point

Use Cases

  • Neuraxial anesthesia (epidurals, spinal blocks)
  • Spinal needle interventions
  • Musculoskeletal diagnostics
  • Chronic pain management
  • Emergency settings (Accuro 3S-MIL)
  • Military use cases (Accuro 3S-MIL)

What Physicians Need to Know

DICOM Support & Standards
Accuro 3S supports DICOM-based patient and image archival workflows.
PACS Integration Method
Interfaces with healthcare IT networks to implement DICOM-based workflows, with image storage in an external PACS.
Reading Room Workflow Impact
Designed for point-of-care neuraxial and regional anesthesia procedures, streamlining complex spinal and epidural procedures. It addresses the 'three-hands problem' with a needle guide kit, enhances first-attempt success rates, and reduces needle redirections and paresthesia instances.
AI Model Architecture (deep learning approach)
SpineNav-AIu2122 is a machine learning-based software utilizing an AI-based image processing architecture. It automatically identifies key anatomical structures, indicates spine midline, and detects epidural space and depth. It also employs SpineNav3Du2122 AI-Based Spine Recognition technology for real-time 3D views and automated image reconstruction.
FDA Clearance Pathway (510k/De Novo)
Received 510(k) clearance from the U.S. FDA for the Accuro 3S diagnostic ultrasound system and SpineNav-AIu2122 image processing software. The Accuro 3S Needle Guide Kit also received 510(k) clearance.
Supported Modalities
Diagnostic ultrasound system (point-of-care). Clinical applications include musculoskeletal conventional and superficial imaging, and guidance for needle or catheter placement, particularly for neuraxial anesthesia. It serves as a non-radiation-based alternative.
Sensitivity & Specificity Data
The AI-enabled SpineNav3Du2122 Image Recognition technology demonstrates epidural location identification success rates exceeding 94%. Previous versions of Accuro with SpineNav3Du2122 have been noted for their sensitivity and specificity in automated software.
Physician Tip

Accuro 3S with SpineNav-AIu2122 is particularly beneficial for neuraxial and regional anesthesia, offering real-time ultrasound guidance for precise needle placement. Its AI-driven automated landmark detection and depth measurement can significantly improve first-attempt success rates, especially in patients with challenging anatomies (e.g., obesity, scoliosis). The system's design, including the needle guide kit, helps overcome the 'three-hands problem,' enhancing workflow efficiency and potentially reducing procedure times and patient discomfort. It's a valuable tool for both experienced practitioners and trainees, as it can standardize interpretation and reduce training requirements.

Accuro 3S is designed for seamless integration into existing healthcare IT environments through its DICOM compliance. This allows for straightforward archival of patient images and data into external PACS systems, ensuring that imaging records are consistently managed within the hospital's infrastructure. Its point-of-care nature means it can complement existing imaging workflows without requiring complex, deep integration into radiology reading room systems, focusing instead on procedural guidance and documentation.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Starts at $5,999 usd (for accuro product line) — Starts at $5,999 USD; No cloud subscription required
DeploymentPortable, point-of-care ultrasound system
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Accuro 3S diagnostic ultrasound system and SpineNav-AI™ image processing software received 510(k) clearance from the U.S. FDA on July 15, 2025, for anatomical guidance during needle or catheter placement. The Accuro 3S Needle Guide Kit consumables also received 510(k) clearance on December 16, 2025. The K-number K243937 for Accuro 3S, an Ultrasonic Pulsed Echo Imaging System, was cleared on May 23, 2025.

Integrations
EHR Not specified
Specialties Anesthesiology, Interventional Radiology, Physical Medicine & Rehab

What the Web Says

The Accuro 3S by Rivanna Medical is generally well-regarded for its ability to improve the accuracy and efficiency of neuraxial anesthesia procedures, particularly spinal and epidural injections. Reviewers highlight its potential to reduce complications and improve patient safety by providing real-time ultrasound guidance. However, some concerns exist regarding its cost and the learning curve associated with integrating new technology into existing clinical workflows.

Overall: Positive

Strengths

  • Improved accuracy in identifying epidural space and spinal anatomy.
  • Potential to reduce 'sticks' and improve first-pass success rates.
  • Enhanced patient safety by minimizing complications like dural puncture.
  • Real-time ultrasound guidance for neuraxial procedures.
  • User-friendly interface and intuitive design.
  • Positive impact on training for residents and new practitioners.

Limitations

  • High initial cost of the device can be a barrier for some institutions.
  • Requires training and adaptation for clinicians not familiar with ultrasound guidance.
  • Integration into existing clinical workflows can be challenging.
  • May not be universally adopted due to established traditional techniques.
  • Limited long-term studies on widespread cost-effectiveness.
  • Potential for over-reliance on technology, diminishing anatomical palpation skills.

Based on reviews from: Reddit (anesthesiology forums), Healthcare IT News, Physician reviews (various medical journals and forums), Anesthesiology conferences and presentations, Rivanna Medical product literature

Last updated: 2026-07-22

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Press & Coverage

Rivanna Medical
Accuro 3S: Precision in Action
The Accuro 3S will introduce an innovative approach to neuraxial ultrasound with AI-enabled software, a unique probe design, and a novel patient drape to enhance probe stability and streamline spinal and epidural procedures.
2024-11
Rivanna Medical
RIVANNA Has Anesthesiology's Back in Epidural Injections
RIVANNA's second-generation Accuro 3S, FDA-cleared in 2025 and slated for limited market release in late 2026, features powerful AI for automated, real-time image guidance and a modified design to enable single-clinician operation.
2026-03
PR Newswire
RIVANNA announces FDA clearance of Accuro 3S Needle Guide Kit
RIVANNA announced that the U.S. FDA granted 510(k) clearance for its Accuro 3S Needle Guide Kit consumables, designed for use with the Accuro 3S ultrasound imaging system to enhance safety and effectiveness of ultrasound-guided needle placement.
2025-12
Medical Device Network
Rivanna gets FDA nod for ultrasound platform and AI software
Rivanna Medical received 510(k) approval from the FDA for its Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing software, enabling their use in US hospitals for anatomical guidance during needle or catheter placement.
2025-07
Diagnostic Imaging
FDA Clears Point-Of-Care Ultrasound Platform and AI Software for Neuraxial Procedures
The FDA granted separate 510(k) clearances for the Accuro 3S point-of-care ultrasound system and SpineNav-AI machine learning software, aiming to overcome traditional challenges in ultrasound-guided neuraxial procedures.
2025-07
Rivanna Medical
RIVANNA's next-generation ultrasound guidance platform and AI-driven imaging software receive FDA 510(K) clearance
RIVANNA announced FDA 510(k) clearance for its Accuro 3S diagnostic ultrasound system and SpineNav-AI image processing software, authorizing their use in U.S. hospital and clinical settings for anatomical guidance during needle or catheter placement.
2025-07
Towards Healthcare Research & Consulting
Rivanna Selected for Medtech Innovator 2025 | Accuro 3S Ultrasound Tech
Rivanna was selected for the Medtech Innovator 2025 accelerator program due to its AI-powered Accuro 3S ultrasound device, which is designed to improve safety in spinal and epidural procedures by providing real-time image-guided needle placement.
2025-06
Rivanna Medical
The Inflection Point for Neuraxial Guidance
Accuro 3S, FDA-cleared in 2025, is the first device specifically designed to provide real-time in-plane needle guidance during neuraxial anesthesia, offering continuous needle tip tracking and trajectory guidance.
2026-07

Videos

Product demos, reviews, and walkthroughs for Accuro 3S.

View all on YouTube

Frequently Asked Questions

Accuro 3S is a portable, point-of-care ultrasound system with integrated SpineNav-AI software designed for neuraxial anesthesia and needle/catheter placement. Its AI-enabled software provides real-time needle visualization, automated identification of key anatomical landmarks, and helps address challenges like the 'three-hands problem' by enhancing probe stability and enabling continuous, in-plane needle tracking.
Accuro 3S, along with its SpineNav-AI software, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), authorizing its use in United States hospital and clinical settings for anatomical guidance during needle or catheter placement. The system also features healthcare IT connectivity to implement DICOM-based patient and image archival workflows, which typically adhere to established healthcare data security and privacy standards.
While Accuro 3S aims to overcome traditional challenges in neuraxial procedures, such as reliance on blind palpation and difficulty with real-time needle visualization, specific limitations of the Accuro 3S system itself are not explicitly detailed in the provided information. However, as a new technology, its broader market launch is still forthcoming, and like any advanced medical device, it would require proper training and understanding of its capabilities to maximize its benefits.
Yes, other AI-based tools exist in the market for ultrasound-guided regional anesthesia. For example, GE Healthcare offers the cNerve tool, an AI-based auto tool for real-time guidance in nerve blocks. Accuro 3S also presents a non-radiation-based alternative to traditional fluoroscopy for image guidance in chronic pain management.
Specific pricing for the Accuro 3S system is not explicitly stated in the available information. However, its predecessor, the Accuro neuraxial guidance system, has a starting price of $5,999 USD and does not require a cloud subscription. It is common for advanced medical devices like Accuro 3S to involve an initial purchase cost and potentially service plans or consumable product costs, such as the Accuro 3S Needle Guide Kit.
The SpineNav-AI software in Accuro 3S provides automated landmark detection and identifies critical spinal anatomy, including the spine midline and the position and depth of the epidural space. Clinical studies on the earlier Accuro system with similar AI (SpineNav3D) demonstrated success rates exceeding 94% for automated epidural location identification and accuracy within 3mm of expert manual measurements.
Accuro 3S is designed to enhance workflow by enabling clinicians to visualize the epidural space, assess its depth, and insert needles under live guidance. The system includes features like 'TeachAssist' to aid training in academic medical centers, allowing supervising physicians to provide real-time guidance. It also supports healthcare IT connectivity for DICOM-based patient and image archival workflows, facilitating integration into existing hospital systems.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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