Novocure, GmbH: FDA clearances and approvals
Novocure, GmbH has 0 FDA 510(k) clearances, plus 3 PMA decisions, across 3 product codes in 3 review panels. It is the industry lead sponsor of 18 device clinical trials on ClinicalTrials.gov. It files with the SEC as NovoCure Ltd (NVCR).
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Novocure, GmbH is the industry lead sponsor of 18 device studies on ClinicalTrials.gov (4 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)
- NCT06390059: EF-39 PANOVA-4: Study of Tumor Treating Fields Concomitant With Atezolizumab, Gemcitabine and Nab-Paclitaxel as First-LineTreatment for Metastatic Pancreatic Ductal Adenocarcinoma (Completed, started 2023-08-28)
- NCT05538806: TTFields in General Routine Clinical Care in Patients With Pleural Mesothelioma Study (Recruiting, started 2023-08-01)
SEC filings
NovoCure Ltd (NVCR): EDGAR filings, CIK 1645113. Matched by exact company name.
Frequently asked questions
How many FDA 510(k) clearances does Novocure, GmbH have?
Novocure, GmbH has 0 FDA 510(k) clearances, plus 3 PMA decisions, across 3 product codes in 3 review panels.
What devices does Novocure, GmbH make?
Its most frequent FDA product codes 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).
Has Novocure, GmbH had device recalls?
openFDA lists no recalls under a recalling firm name matching Novocure, GmbH. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.