Accuro 3S
See the midline. Then advance with guidance.
Neuraxial placement has long relied on palpated landmarks and tactile confirmation. Loss of resistance still completes the procedure; what has been missing is real-time anatomical guidance during the needle's approach to the epidural space.
Accuro® 3S is the first FDA-cleared, AI-enabled, real-time ultrasound guidance system built for neuraxial anesthesia. It brings automated landmark identification, epidural-depth measurement, and real-time in-plane needle tracking into a single-operator, point-of-care workflow.
Applications are open for a limited cohort of pre-commercial sites.
Why Now
The conditions for real-time guidance have converged.
Real-time neuraxial guidance is no longer waiting on a single breakthrough. The clinical need is better defined. Guided procedures can be identified in inpatient data. The infrastructure exists to evaluate outcomes across centers. Purpose-built technology now overcomes workflow barriers that conventional ultrasound could not address.
Unintended dural puncture is increasingly understood as a potential source of persistent morbidity, not simply an acute complication.
A dedicated ICD-10-PCS code takes effect October 1, 2026, creating a way to identify computer-aided neuraxial guidance in inpatient data.
MPOG provides a path to evaluate guided procedures across institutions and build evidence beyond single-center experience.
Accuro 3S addresses the barriers of probe geometry, anatomy interpretation, and single-operator workflow that limited continuous midline guidance.
The Dual-Array Probe
Keep the needle in plane and on midline.
Two side-by-side curvilinear arrays flank a central aperture in the patented Dual-Array® probe. The needle advances through that aperture along the spinal midline, within the imaging plane: an approach conventional probe geometry cannot support. Paired with SafeTrack™, the design brings real-time anatomical imaging and continuous needle-tip feedback into one midline workflow.
In-plane midline approach
Track the needle through advancement.
How It Works
Anatomical guidance before loss of resistance.
Real-time neuraxial guidance does not require clinicians to abandon the skills that define expert practice. The loss-of-resistance technique remains the endpoint; what changes is the quality of anatomical guidance and needle tracking available in the approach to that endpoint.
Identify the anatomy in real time.
SpineNav-AI™ identifies lumbar landmarks, indicates the midline, and measures depth to the epidural space in real time. AnatomyView™ overlays color-coded labels on the live image, supporting interpretation without dedicated ultrasound training.
Track the needle tip continuously.
SafeTrack provides needle-tip depth and trajectory, tracked relative to the target anatomy as the needle advances in the midline plane.
Free both hands for the procedure.
Continuous guidance normally requires one hand for the probe and two for the needle and syringe. Elastic bands integrated into the kit's sterile drape secure the Dual-Array probe against the patient's back, leaving both hands on the procedure: needle advancement, loss-of-resistance confirmation, and catheter placement.
SpineNav-AI Performance
Published results, FDA clearance K243937.
Specifications and Components
Explore the system in detail.
The system +
- Modality. Portable, point-of-care diagnostic ultrasound.
- Dual-Array probe. Two side-by-side 64-element curvilinear transducer arrays separated by a central aperture; center frequency of 3.5 to 4.0 MHz; approximate −6 dB bandwidth of 2 to 5 MHz; 480-micron pitch; 50 mm radius of curvature.
- Computer and Display 1.0. Medical-grade panel computer with a 15.6-inch full-HD multi-touch display on an articulated, locking arm; antimicrobial housing; TPM 2.0 hardware security.
- Tower and Power Unit. Cart-based system with an onboard lithium-ion battery supporting up to four hours of continuous imaging; full recharge in under six hours when powered off; PACS and DICOM connectivity.
Consumables, the Needle Guide Kit +
The single-use, sterile SafeTrack Needle Guide Kit is designed for the Accuro 3S system and Dual-Array probe.
- Needle Guide with Integrated Probe Cover. Aligns the needle with the imaging plane. The cover contains preloaded coupling gel between the transducer and sleeve.
- Ultrasound Gel. Provides the skin interface between the sleeved probe and the patient.
- Patient Drape with Integrated Elastic Bands. Secures the probe against the patient during imaging and needle advancement.
- SafeTrack Tuohy Needle. 17G by 3.5 inches, with an integrated tracking element on the hub.
- Spinal Needle. 25G by 5 inches, pencil-point, for combined spinal-epidural procedures.
Clinical Foundation
Extending a clinically validated foundation.
The Accuro 3S platform builds on the evidence established by the flagship Accuro device. In a randomized trial of 80 obese parturients, first-insertion success was 72.5% with Accuro and 40.0% with palpation (p=0.003). Across five randomized trials, peer-reviewed evidence for the Accuro platform spans 369 patients.
Sources: Ni et al., Journal of Anesthesia 2021 (obese parturients, first-insertion success); Sharapi et al., 2025 (meta-analysis, five RCTs, n=369). Evidence pertains to the flagship Accuro platform.
Accuro 3S is designed to improve first-insertion success and reduce needle passes. The Pioneer and Trailblazer programs will evaluate device-specific outcomes of real-time guidance in practice.
Platform Adoption
Deployment, account, and procedure figures reflect the flagship Accuro platform (company data, Q2 2026).
Clinician Perspectives
Voices from the specialty.
Anesthesiologists describe where real-time neuraxial guidance could add value and how Accuro 3S may fit into clinical practice.
The Trailblazer Program
Shape the standard before it sets.
The Pioneer Partner cohort is full. RIVANNA is now reviewing applications for 25 Trailblazer sites that will receive pre-commercial access beginning in Q2 2027. Selected sites will contribute real-world outcomes and workflow insight before planned commercial availability in 2028.
Accuro 3S is a portable, point-of-care diagnostic ultrasound system FDA 510(k) cleared for guidance of needle or catheter placement. A typical examination is guidance of neuraxial anesthesia. The Accuro 3S diagnostic ultrasound system, the integrated SpineNav-AI image processing software, and the Accuro 3S Needle Guide Kit consumables are FDA 510(k) cleared. Clearance numbers: K243937 and K250469. SafeTrack continuous needle tracking and the SafeTrack-enabled Needle Guide Kit (K261014) are pending FDA clearance.