OverviewAccuro 3S is an FDA-cleared, AI-enabled, real-time neuraxial ultrasound guidance system designed for single-operator point-of-care use during neuraxial anesthesia. It integrates automated landmark identification, epidural-depth measurement and continuous in‑plane needle-tip tracking to support clinical decision-making while preserving traditional loss-of-resistance confirmation.
Key features- Real-time anatomical guidance during needle approach to the epidural space while maintaining loss-of-resistance as the clinical endpoint.
- Automated landmark identification and midline indication via SpineNav-AI™.
- Real-time epidural-depth measurement displayed to the operator.
- SafeTrack™ continuous in-plane needle-tip tracking (provides needle-tip depth and trajectory relative to target anatomy).
- Single-operator workflow enabled by hands-free probe stabilization using an integrated sterile drape.
- Purpose-built Dual-Array® probe geometry (two side-by-side curvilinear arrays with a central aperture) to keep the needle in plane and on midline.
How it worksSpineNav-AI™ detects lumbar landmarks and indicates midline while AnatomyView™ overlays color-coded labels on the live image to aid interpretation without dedicated ultrasound training. SafeTrack™ continuously reports the needle-tip position relative to target anatomy during midline in‑plane advancement. Elastic bands in the sterile drape secure the Dual-Array probe, allowing the operator to free both hands for needle advancement, loss-of-resistance confirmation and catheter placement.
Components and consumables- System modality: Portable, point-of-care diagnostic ultrasound with optional cart-based Tower and Power Unit (onboard lithium-ion battery).
- Dual-Array probe: Two side-by-side 2–5 MHz curvilinear arrays separated by a central aperture for midline, in-plane needle advancement.
- Computer and Display: Medical-grade panel computer with 15.6-inch full-HD multi-touch display on an articulated locking arm; antimicrobial housing and TPM 2.0 hardware security.
- Tower and Power Unit: Cart-based option with onboard lithium-ion battery supporting up to four hours of continuous imaging; full recharge under six hours when powered off; PACS and DICOM connectivity.
- Sterile, single-use SafeTrack Needle Guide Kit (consumables) including: needle guide with integrated probe cover (preloaded coupling gel), ultrasound gel, patient drape with integrated elastic bands, SafeTrack Tuohy Needle (17G × 3.5 in) with integrated tracking element on the hub, and spinal needle (25G × 5 in) for combined spinal-epidural procedures.
Performance and evidencePlatform performance indicators include high epidural detection and anatomy detection targets with sub-millimeter epidural distance accuracy. Published results and FDA clearance (K243937) are referenced. Prior Accuro platform data include a randomized trial in 80 obese parturients showing first-insertion success of 72.5% with Accuro vs. 40.0% with palpation (p=0.003); peer-reviewed evidence for the Accuro platform spans 369 patients across five randomized trials.
Programs and availabilityPre-commercial Trailblazer and Pioneer programs are available for early site access and outcomes evaluation; selected Trailblazer sites will receive pre-commercial access ahead of planned commercial availability in 2028.
RegulatoryFDA clearance is indicated (K243937); published clinical results for the Accuro platform are cited.
Technical specifications- Model: Accuro 3S real-time neuraxial guidance system.
- Probe: Dual-Array® two side-by-side curvilinear arrays, 2–5 MHz, central aperture for in‑plane midline needle approach.
- Display: 15.6-inch full-HD multi-touch medical-grade panel computer.
- Battery: Onboard lithium-ion battery supporting up to 4 hours continuous imaging; full recharge under 6 hours (powered off).
- Connectivity: PACS and DICOM capable.
- Consumables: Single-use SafeTrack Needle Guide Kit (needles: 17G Tuohy 3.5 in; spinal needle 25G 5 in), integrated probe cover with coupling gel, ultrasound gel, patient drape with elastic bands.
- Software/algorithms: SpineNav-AI™, AnatomyView™, SafeTrack™ real-time needle tracking.
- Regulatory/validation: FDA clearance referenced (K243937); peer-reviewed clinical trial data for the Accuro platform.