Rivanna Medical wins first CMS code for real-time neuraxial ultrasound navigation

Rivanna Medical, Inc. has reached an important commercialization milestone for its Accuro 3S ultrasound-navigation platform after the Centers for Medicare & Medicaid Services created ICD-10-PCS code XEZU3HC for computer-aided intraprocedural navigation in the spinal canal using ultrasound imaging with continuous needle tracking. The code becomes effective for inpatient discharges beginning October 1, 2026 and creates the first dedicated national inpatient identifier for this type of real-time neuraxial guidance. Before the change, hospitals could code the underlying spinal or epidural anesthesia procedure but could not separately identify whether computer-aided ultrasound navigation was used, making adoption and outcome comparisons difficult to measure in administrative data. The commercial caveat is equally important: XEZU3HC is a procedure-category code available to qualifying technologies and does not itself establish any separate Medicare payment for Rivanna Medical, Inc., Accuro 3S or the hospital performing the procedure.

That distinction makes the development more strategically interesting than a simple reimbursement headline. Rivanna Medical, Inc. now has a standardized mechanism through which hospitals can identify use of advanced neuraxial guidance and link those cases with clinical and economic outcomes. If future data demonstrate fewer failed insertions, complications or workflow delays, the coding infrastructure can support more sophisticated reimbursement discussions later. In other words, CMS has made the technology visible before making it separately payable.

Why was computer-aided neuraxial guidance previously invisible in hospital data?

Epidural, spinal and combined spinal-epidural procedures are traditionally documented and coded based on the anesthesia intervention itself. A clinician may use palpation, conventional ultrasound assistance or more advanced real-time navigation, but administrative claims historically lacked a dedicated ICD-10-PCS field that consistently separated those workflows. Researchers and hospitals therefore had difficulty comparing guided and unguided cases across large national datasets even when the technologies required substantially different processes.

XEZU3HC changes that by identifying computer-aided intraprocedural navigation using ultrasound imaging with continuous needle tracking during a percutaneous spinal-canal procedure. CMS placed the code in Section X, New Technology, under a newly created XEZ table. The code is not proprietary to Rivanna Medical, Inc. or Accuro 3S, meaning another technology meeting the complete definition could also be reported under it.

That non-proprietary status is important because Rivanna Medical, Inc. cannot claim an exclusive reimbursement moat from the code. Its advantage comes from having developed a product specifically aligned with the workflow CMS has now chosen to identify and from being in a position to gather outcomes data as hospitals begin using the new category.

How does Accuro 3S change the way an epidural or spinal needle is guided?

Accuro 3S is a portable point-of-care ultrasound system using Rivanna Medical, Inc.’s Dual-Array probe, SpineNav-AI software and SafeTrack needle-tracking technology. The two ultrasound arrays sit on either side of a central needle aperture, allowing the clinician to visualize lumbar anatomy while advancing the needle through the middle of the probe. SpineNav-AI identifies structures including the spinal midline and estimates depth to the epidural space, while SafeTrack provides ongoing information about the needle tip and trajectory.

The approach addresses one of the long-standing limitations of neuraxial anesthesia: physicians often identify anatomical landmarks by palpating the patient’s back and then rely heavily on tactile feedback as the needle advances. That process works well in many patients but becomes more difficult where landmarks are obscured by obesity, anatomical variation, previous surgery or other factors. Ultrasound can improve anatomical identification, while real-time navigation attempts to extend imaging from pre-procedure planning into the needle-advancement phase itself.

Rivanna Medical, Inc. received 510(k) clearance for Accuro 3S and its associated AI-based anatomical guidance technology, and FDA records also show subsequent clearance of the Accuro 3S Needle Guide Kit. Those are Class II substantial-equivalence clearances, not FDA premarket approvals, an important regulatory distinction for a device entering a broader hospital rollout.

What clinical evidence suggests ultrasound guidance can improve neuraxial placement?

A randomized controlled study of 80 obese women undergoing elective cesarean delivery compared Accuro-guided combined spinal-epidural placement with traditional palpation. First-insertion success reached 72.5% in the ultrasound group compared with 40% using palpation, a statistically significant difference with a p-value of 0.003. Patients in the ultrasound group also required fewer needle redirections and experienced less paresthesia, while the time needed to identify the puncture site was shorter.

The study provides evidence supporting the broader concept of automated ultrasound assistance, but Rivanna Medical, Inc. itself notes that published clinical evidence from earlier Accuro generations should not automatically be treated as outcomes evidence specific to every feature of Accuro 3S. The newer platform adds continuous tracking and updated AI functionality that must develop its own real-world evidence base. That is one reason the new procedure code matters: guided cases can now be identified more systematically as hospitals generate data using newer technologies.

Beginning in the fourth quarter of 2026, Rivanna Medical, Inc. plans to incorporate XEZU3HC into its outcomes framework where participating institutions assign the code. The company can then potentially examine measures such as procedural success, complications, workflow and resource utilization across hospitals rather than relying entirely on small individual studies.

Why doesn’t the new CMS code automatically create reimbursement?

Procedure coding and payment are related but separate. XEZU3HC tells an inpatient hospital how to identify a qualifying navigated procedure in administrative data, but CMS explicitly has not established a separate incremental payment simply because that code is used. Rivanna Medical, Inc. itself states that the code’s immediate function is identification and that coding, evidence generation and reimbursement typically occur in sequence.

That can still have financial significance over time. Before payers can judge whether a technology merits additional reimbursement, they often need reliable information about how frequently it is used, what outcomes accompany it and whether it changes hospital resource consumption. A dedicated code makes that analysis substantially easier because guided procedures no longer disappear into the same administrative category as conventional techniques.

Hospitals considering Accuro 3S therefore cannot justify the purchase by pointing to an automatic extra Medicare payment from October 1. They have to evaluate whether better first-pass success, reduced complications, lower procedure time or other workflow improvements create enough economic value internally. The code improves Rivanna Medical, Inc.’s ability to measure that proposition rather than solving the proposition by itself.

How has Rivanna Medical, Inc. financed development of its ultrasound platform?

Rivanna Medical, Inc. has attracted substantial non-dilutive government support for its imaging and AI programs. During 2025 alone, the company disclosed a $9.92 million BARDA contractual option for AI module development, a $3 million Department of Defense-related research grant, $2.21 million of NIH support for pediatric lumbar-puncture guidance and an $800,000 Virginia Catalyst award accompanied by matching funds. Earlier BARDA support included a $30.5 million follow-on contract related to the Accuro XV platform.

That funding model is significant for a privately held medical-device company because developing imaging hardware, software, manufacturing processes and regulatory evidence can require substantial capital before revenue reaches scale. Non-dilutive contracts allow Rivanna Medical, Inc. to build technology while reducing dependence on repeated venture-equity financing.

The federal support also points to a broader strategy beyond neuraxial anesthesia. Rivanna Medical, Inc. is developing ultrasound systems for musculoskeletal assessment, trauma and other point-of-care applications, giving the underlying imaging and AI capabilities potential uses across several clinical environments. Accuro 3S nevertheless provides one of the clearest near-term commercial tests because neuraxial anesthesia is common, procedural challenges are well understood and the new CMS code now gives hospitals a standardized way to track adoption.

What needs to happen before XEZU3HC becomes financially meaningful?

The next stage is evidence generation at scale. Hospitals need to show whether real-time computer-aided guidance reduces failed attempts, accidental dural puncture, procedure time, staff burden or downstream complications often enough to justify the cost of equipment, training and disposables. Rivanna Medical, Inc. can then use coded inpatient data to support health-economic analyses that were much more difficult when navigation use could not be identified reliably.

Separate payment could eventually become part of the discussion if evidence demonstrates meaningful incremental value and the relevant reimbursement criteria are satisfied, but no such payment should be assumed today. The October 1 code is an infrastructure milestone, not a reimbursement award.

That distinction actually makes XEZU3HC a useful measure of where Rivanna Medical, Inc. sits commercially. FDA clearance established that Accuro 3S could be marketed. The CMS code establishes that advanced navigated procedures can be identified. The remaining challenge is proving that the clinical and economic outcomes are strong enough for hospitals and payers to treat real-time neuraxial navigation as a standard component of care rather than an optional imaging aid.