Companies
Senseonics
Eversense E3 — Fluorescent optical sensor, 180-day implant.
- Country
- United States
Coverage
| CN | EU | US | |
|---|---|---|---|
| diagnostics-medtech | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Capacity | The company believes contract manufacturers have sufficient capacity to meet requirements | materials.proxyvote.com |
| Certification | Received certification from BSI, a Notified Body to the International Standards Organization | materials.proxyvote.com |
| Regulatory approval | Eversense E3 approved by FDA (180-day) and received CE Mark (6-month). Eversense 365 approved by FDA and CE Mark. | diatribe.org · fda.gov · senseonics.com |
| Production site | Manufacturing is outsourced to contract manufacturers across North America and Europe. | materials.proxyvote.com |
| Revenue | Full year 2025 revenue of $35.3 million | senseonics.com |
Independent sources: diatribe.org · fda.gov · materials.proxyvote.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Implantable biosensors for chronic disease | diagnostics-medtech | Medium | → |
| Wearable biodiagnostics | diagnostics-medtech | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.