See the anatomy. Advance with guidance.
Accuro® 3S is the first FDA-cleared, real-time neuraxial guidance system, combining AI-enabled landmark identification with continuous needle-tip tracking. One single-operator workflow.
For decades the obstacle was geometry. A conventional ultrasound probe cannot hold a midline needle in plane, so the approach to the epidural space went unseen. Accuro 3S solves the geometry and brings guidance into the procedure.
Selected programs gain early access to Accuro 3S ahead of broad availability, planned for 2028.
A probe built for midline needle advancement.
Two side-by-side curvilinear arrays flank a central aperture. The aperture opens a path down the midline, so the needle advances within the imaging plane rather than crossing it. The result is an in-line midline approach that conventional single-array probes cannot support, with the needle and the target anatomy in the same imaging plane.
Four components turn a blind procedure into a guided one.
Accuro 3S follows the sequence clinicians already use: identify the lumbar midline and interlaminar space, measure depth to the epidural space, then advance the needle with continuous tip feedback. Loss of resistance remains the clinical endpoint for epidural placement. What changes is the quality of anatomical guidance available in the distance before that confirmation.
Identify
See the spine in real time. SpineNav-AI™ identifies lumbar landmarks, indicates the midline, and measures depth to the epidural space. AnatomyView™ overlays color-coded anatomical segmentation and labels on the SpineNav-AI image, standardizing interpretation across experience levels.
Align
Align the needle with the imaging plane. The needle advances in-line through the Dual-Array probe's center and stays within the imaging plane from skin entry onward.
Track
Advance the needle with continuous trajectory feedback. SafeTrack™ tracks needle-tip depth and trajectory in real time throughout midline advancement. The Needle Tip Indicator appears on the image the moment the tip enters the field of view.
Confirm
Confirm entry with both hands free. Loss of resistance confirms entry while the patient drape's integrated elastic bands hold the probe in place against the patient.
Explore the system in detail.
The system
Dual-Array probe
Two 64-element curvilinear arrays with a central aperture; center frequency 3.5 to 4.0 MHz, -6 dB bandwidth 2 to 5 MHz, 480-micron pitch, 50 mm radius.
Computer and Display
A medical-grade panel computer with a 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
A cart-based system with an onboard lithium-ion battery providing up to six hours of continuous imaging and a full recharge in under six hours when powered off, with PACS and DICOM connectivity.
Consumables: the SafeTrack Needle Guide Kit
A single-use, sterile kit designed for use with the Accuro 3S system and the Dual-Array probe. Five components:
Probe Cover with Integrated Needle Guide
Aligns the needle with the imaging plane; the cover carries an integrated coupling pad between the transducer and the sleeve.
Sterile Ultrasound Gel
A separate packet for the skin interface between the sleeved probe and the patient.
Patient Drape with Integrated Elastic Bands
Two bands secure the probe against the patient during imaging and advancement.
SafeTrack Tuohy Needle
17G by 3.5 inches, with the integrated tracking element on the hub.
Spinal Needle
25G by 5 inches, pencil-point, for combined spinal-epidural procedures.
System at a glance
| Modality | Portable, point-of-care diagnostic ultrasound |
|---|---|
| AI software modules | SpineNav-AI, AnatomyView, BoneEnhance®, SafeTrack |
| Probe | Dual-Array: two 64-element curvilinear arrays with a central aperture |
| Display | 15.6-inch medical-grade full-HD multi-touch |
| Power and mobility | Cart-based tower; battery up to 6 hours continuous imaging |
| Connectivity | PACS and DICOM |
| Consumables | SafeTrack Needle Guide Kit (single-use, sterile; five components) |
| Regulatory | The Accuro 3S diagnostic ultrasound system with SpineNav-AI, the system with SafeTrack needle-tip tracking, the Needle Guide Kit, and the Needle Guide Kit with the SafeTrack needle are FDA 510(k) cleared. SafeTrack is cleared for use with SafeTrack-compatible needles. |
Built on a clinically validated platform.
SpineNav-AI is the machine-learning software on Accuro 3S. It identifies lumbar spine anatomy, indicates the spine midline, and estimates depth to the epidural space. The validation supporting its FDA clearance, reported in the 510(k) summary, used 10,080 image frames from 81 individuals at seven geographically diverse sites: a test dataset kept fully separate from development, measured against a ground truth set by a panel of three board-certified radiologists. Per-frame detection of the Epidural Region Indicator was 95.5%, against a 70% acceptance criterion set in advance; depth accuracy was 2.42 (±3.41) mm and lateral accuracy 1.61 (±2.57) mm.
Voices from the specialty.
Three short videos: anesthesiologists on the role they see for real-time neuraxial guidance, and what Accuro 3S could mean for their practice.
Shape the standard before it sets.
The Pioneer Partner Program cohort is full, and broad availability is planned for 2028. Until then, Trailblazer is how programs bring Accuro 3S in: a 2027 cohort capped at 25 programs, with applications reviewed as they arrive. Selected programs gain early market access and shape the clinical workflow before broad availability.
Source: FDA 510(k) K243937, AI Summary of Tests (SpineNav-AI validated on a test set independent of the training data; acceptance criteria of 70% per-frame accuracy and 80% per-sequence detection, both exceeded). Validation measures, not procedural success.