Monitor for completion of MDR conformity assessment and CE marking announcement, which would unlock EU market access for the Lumee Oxygen Platform. Also watch for any update on the G3 Vision Labs option exercise.
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Executive Summary
Profusa received a positive decision from GMED regarding ISO 13485 certification of its quality management system, a key step toward CE marking for the Lumee Oxygen Platform in the EU. The company also holds an option to acquire G3 Vision Labs, but no financial terms or timeline for CE marking are provided.
Key Facts
- Profusa received a positive decision from GMED on ISO 13485 certification of its quality management system.
- GMED is a notified body under the EU Medical Device Regulation (MDR).
- The company continues working toward MDR conformity assessment for the Lumee Oxygen Platform.
- CE marking would allow sales in the 27 EU member states.
- Profusa has an option to acquire G3 Vision Labs, but no exercise or financial terms are disclosed.
Financial Impact
No financial figures disclosed; CE marking would enable EU market access but timeline and revenue impact are uncertain.
Risk Factors
- No assurance on timing or outcome of remaining GMED assessment activities.
- CE marking timeline is uncertain and could be delayed.
- Option to acquire G3 Vision Labs may not be exercised; no financial details provided.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3368215 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 15, 2026 12d ago | Press Release | $1.07 $1.02 | ▼ −4.67% | ▼ −3.66% | $0.7800 (−27.10%) |
Oct 15, 2026 12d ago | 8-K | $1.07 $1.02 | ▲ +4.67% | ▲ +3.66% | $0.7800 (+27.10%) |
Oct 9, 2026 17d ago | 8-K | $1.30 $0.9002 | ▲ +30.75% | ▲ +29.26% | $0.7800 (+40.00%) |
Oct 5, 2026 22d ago | 8-K | $1.75 $1.30 | ▼ −25.71% | ▼ −26.14% | $0.7800 (−55.43%) |
Sep 24, 2026 4w ago | Press Release | $3.03 $1.87 | ▼ −38.28% | ▼ −37.87% | $0.7800 (−74.26%) |
Sep 16, 2026 5w ago | 8-K | $1.78 $2.05 | ▼ −15.17% | ▼ −12.61% | $0.7800 (+56.18%) |
Sep 15, 2026 6w ago | 8-K | $1.83 $1.91 | ▲ +4.37% | ▲ +3.55% | $0.7800 (−57.38%) |
Sep 1, 2026 8w ago | 8-K | $2.88 $2.47 | ▲ +14.24% | ▲ +14.32% | $0.7800 (+72.92%) |
Aug 31, 2026 8w ago | 8-K | $3.00 $2.88 | ▼ −4.00% | ▼ −3.86% | $0.7800 (−74.00%) |
Aug 20, 2026 9w ago | 8-K | $7.57 $4.24 | ▲ +43.99% | ▲ +45.10% | $0.7800 (+89.70%) |
US Market Status
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