Profusa Announces Significant Progress Towards Lumee® Oxygen Platform CE Mark with ISO 13485 Certification Expected in Early October
Profusa received a positive decision from EU notified body GMED certifying its quality management system to ISO 13485, a key step toward CE marking of the Lumee Oxygen Platform. The company still must complete remaining MDR conformity assessment activities; no assurance was given on the timing or outcome of CE marking.
Key figures
- Drug Name
- Lumee Oxygen Platform
- Certification
- ISO 13485 (positive decision from GMED)
- Expected certification timing
- early October
AI analysis
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