RegulatoryJun 12, 2026, 08:01 AM
Profusa Submits Response for Lumee Oxygen Platform CE Mark
AI Summary
Profusa, Inc. announced the submission of its response package to GMED, its European Notified Body, for the Lumee® Oxygen Platform's MDR conformity assessment. This action follows successful Stage 1 and Stage 2 assessments and is a crucial step towards obtaining CE Mark certification, enabling commercialization in Europe. The submission included updates to technical documentation, quality system evidence, clinical evaluation, and validation information. While CEO Ben Hwang highlighted this as a significant milestone, the company noted that the timing and outcome of GMED's review remain uncertain.
Key Highlights
- Profusa submitted its response package to European Notified Body, GMED.
- This advances the MDR conformity assessment for the Lumee® Oxygen Platform.
- The submission is a key step towards obtaining CE Mark certification.
- CE Mark is essential for commercializing the Lumee® Oxygen Platform in Europe.
- Response package included updates on technical documentation and quality system.
- CEO Ben Hwang called it a "meaningful milestone" in the review process.
- The Lumee® Oxygen Platform provides continuous, real-time tissue oxygen monitoring.
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