Companies
Nevro Corp
its HFX iQ spinal cord stimulation system, which integrates AI-driven personalization (HFX AdaptivAI) with its 10 kHz therapy, received CE Mark certification in Europe in November 2024 and holds an FDA-specific indication for non-surgical back pain, based on the SENZA-NSRBP randomized controlled trial.
- Country
- United States
- Ticker
- NVRO
AI-personalized SCS
CE Mark
us
Coverage
| CN | EU | US | |
|---|---|---|---|
| regenerative-personalized | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Certification | CE Mark certification for HFX iQ spinal cord stimulation system in Europe (2024-11-12) | intl.nevro.com · massdevice.com · prnewswire.com |
| Regulatory approval | FDA approval for HFX iQ system in the United States (2022-01-01) | intl.nevro.com · prnewswire.com · sec.gov |
| Regulatory approval | FDA approval for HFX AdaptivAI in the United States (2024-09-24) | trial.medpath.com · prnewswire.com · sec.gov |
| Revenue | $408.5 million for full-year 2024 worldwide revenue (2024-12-31) | last10k.com |
| Production site | Manufacturing facility in Costa Rica | prnewswire.com · sec.gov |
Independent sources: intl.nevro.com · last10k.com · massdevice.com · prnewswire.com · sec.gov · trial.medpath.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Bioelectronic medicine & neuromodulation | regenerative-personalized | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
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