Boston Scientific
its LUX-Dx insertable cardiac monitor line has cleared multiple FDA 510(k)s, though the company issued an FDA recall in 2026 addressing a LUX-Dx II monitoring-system malfunction.
- Country
- United States
- Ticker
- BSX
Commercial
LUX-Dx insertable cardiac monitor
Coverage
| CN | EU | US | |
|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Implantable biosensors for chronic disease | diagnostics-medtech | Medium | → |
Compiled by BIOECON via the bioecon-brief pipeline.
Compliance
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