We generate the evidence. We also watch it.
A standing brief on what's moving in interventional pain and neuromodulation evidence — regulatory action, trial results, payer policy, publications — from the team building the registries underneath it. Briefings, not press releases. Written for the people inside the decisions.
FDA finalized its real-world evidence guidance for devices. The evidence bar for neuromodulation just shifted.
FDA's final guidance on the use of real-world evidence to support regulatory decision-making for medical devices supersedes the 2017 framework. Two things matter most for SCS, DRG, PNS, and restorative neurostimulation sponsors: FDA no longer requires identifiable, patient-level data in every RWE submission — opening the door to de-identified and aggregate registry data — and every submission now needs a documented relevance and reliability assessment of the data source, the study design, and the analysis.
We've been building toward this. Provenance, audit trail, and instrument validity are now the questions FDA asks first. The briefing covers what the guidance actually requires, where most sponsors will fall short, and the architectural decisions that determine whether a registry counts.
Read the final guidance at FDA.gov ›- Provenance from day one. Audit trails cannot be applied retroactively — the data environment has to be Part 11-ready before the first patient enrolls.
- Fit-for-purpose instruments. Validated PROs captured on a pre-specified schedule, not ad hoc outcomes pulled from charts after the fact.
- One governed dataset. Commercial insights and regulatory-grade evidence drawn from the same patients, so nothing has to be gathered twice.
What's moving in pain and neuromodulation evidence.
Filter by beat. Every briefing links to its primary source.
The Ambulatory Specialty Model starts January 1, 2027 — and low back pain specialists can't opt out
CMS finalized a mandatory two-sided risk model for specialists treating Medicare low back pain episodes in roughly a quarter of U.S. metro areas, with Part B adjustments of up to ±9% in the first payment year. Performance is measured on cost, quality, and care coordination — which makes practice-level outcomes data the difference between a bonus and a penalty.
CDRH's RWE town hall: what "relevance and reliability" means when FDA reviews a registry
FDA's February 2026 town hall walked industry through the final device RWE guidance and its 60-day transition. The takeaways for post-market registries: document provenance up front, pre-specify the analysis, and expect FDA to review the data source as closely as the result.
Five-year real-world data at NANS 2026: SCS and DRG reduce pain-related healthcare visits
Abbott presented real-world data analyses at NANS 2026 showing sustained reductions in pain-related healthcare utilization for patients on BurstDR™ SCS and DRG stimulation. Utilization is the outcome payers actually price — and the analyses are a template for what a commercial registry can produce.
A 24-month real-world SCS cohort: 61% pain reduction at 3 months, 43% at 24
Seventy-six patients, five follow-up windows, multilevel modeling across 452 observations. The durability curve — steep early relief that partially regresses by year two — is the shape real-world SCS data keep producing, and the reason follow-up completion past 12 months matters more than the headline number.
Neuromodulation consolidates: Medtronic–SPR, Boston Scientific–Nalu, Globus–Nevro
Three acquisitions in under a year — $650M for SPR's temporary PNS system, $533M for Nalu, $250M for Nevro. Acquirers are paying for clinical evidence and reimbursement depth as much as for hardware. For every other sponsor in the space, the post-market evidence base just became a valuation line item.
361 HCT/P enforcement is reshaping the amniotic and placental playbook
With enforcement discretion long over, real-world evidence infrastructure isn't optional for this category anymore. What sponsors in the space are building, and why a commercial registry is the new pilot study.
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No filler. Sent when something material moves in pain or neuromodulation evidence — we publish when it matters, not on a schedule. Sponsors, clinician-researchers, payers, and the curious. Unsubscribe anytime.
Because we're in the field, not adjacent to it.
Celéri Health is the evidence infrastructure for interventional pain and neuromodulation. We build the registries sponsors run their post-market programs on. We operate the PainRWD™ Science Cloud. We hold the Part 11-ready EDC that regulatory-grade evidence depends on.
That means when FDA moves, when a sponsor publishes, when a payer rewrites a coverage policy, when a competitor drops new data — we have a position. Not a hot take. A position grounded in what the data actually does.
Regulatory
FDA guidance, CDRH activity, and what each change means for post-market, PMA supplement, and label-expansion evidence.
Trial results
Pivotal and post-market readouts — with attention to the responder definitions and follow-up windows behind the headline number.
Coverage and payer
CMS, commercial, and workers' comp policy — where evidence requirements are heading and what a dossier will need to show.
Biologics
361 HCT/P enforcement, regenerative medicine, and the evidence infrastructure the category now requires.
Publications
What lands in the journals — what a paper establishes, what its methods section concedes, and what it adds to the debate.
Industry
Acquisitions, launches, and reimbursement moves — and what each says about the value of a post-market evidence base.
Celéri Research
Celéri Health's own publications, congress abstracts, and dataset milestones — and why we sequence them the way we do.
Reading the field is one thing. Building the evidence is another.
If a briefing changes what you need to prove, Celéri Health will map that objective to the right evidence track and stand up the infrastructure to get there.
