Novocure, GmbH: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Novocure, GmbH”, plus 3 PMA decisions, across 3 product codes in 3 review panels. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NZK | Stimulator, Low Electric Field, Tumor Treatment | 1 | 0 |
| SDA | Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer | 1 | 0 |
| SHC | Low Electric Field Generator For Pancreatic Cancer Treatment | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250034 | PMA | Optune Pax | 2026-02-11 |
| P230042 | PMA | Optune Lua | 2024-10-15 |
| P100034 | PMA | NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT | 2011-04-08 |
Recalls
openFDA lists no recalls under a recalling firm named Novocure, GmbH.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Novocure, GmbH is the lead sponsor of 7 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06556563: EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma (Recruiting, started 2025-02-03)
- NCT06558799: LUNAR-4: Effect of Tumor Treating Fields (TTFields) (150 kHz) Concurrent With Pembrolizumab for Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC) (Active not recruiting, started 2024-10-14)
- NCT06216301: LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC (Recruiting, started 2024-07-31)
- NCT04953234: Effect of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Best Standard of Care for the Treatment of Hospitalized COVID-19 Patients and Continued Treatment Following Discharge (Completed, started 2021-02-23)
- NCT04492163: Open-Label Pilot Study of OPTUNE® With High Density Transducer Arrays for the Treatment of Recurrent GBM (Completed, started 2020-07-14)
Frequently asked questions
How many FDA 510(k) clearances are listed under Novocure, GmbH?
FDA lists 0 510(k) clearances under the applicant name “Novocure, GmbH”, plus 3 PMA decisions, across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Novocure, GmbH?
The most frequent FDA product codes under this applicant name are NZK (Stimulator, Low Electric Field, Tumor Treatment, 1); SDA (Electrical Tumor Treatment Fields For Non-Small Cell Lung Cancer, 1); SHC (Low Electric Field Generator For Pancreatic Cancer Treatment, 1).
Next steps
- See all 0 Novocure, GmbH clearances with predicates and recalls
- Run predicate analysis for product code NZK, Novocure, GmbH's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.