Profusa Advances EU CE Mark Process for Lumee Oxygen Platform
PFSA•Profusa has submitted a response package to GMED addressing technical documentation, quality system evidence, clinical evaluation activities and validation for its Lumee Oxygen Platform’s EU MDR conformity assessment. This milestone advances the company’s pursuit of CE Mark certification, a key step toward commercializing continuous tissue oxygen monitoring in Europe.
1. Submission of Response Package
On June 12, Profusa submitted its response package to GMED following completion of Stage 1 and Stage 2 quality system and technical documentation assessments. The submission addresses questions raised during the MDR conformity assessment for the Lumee Oxygen Platform.
2. Contents of the Response Package
The package includes updated technical documentation, evidence of quality system compliance, clinical evaluation activities and supporting validation information. These updates are designed to satisfy GMED’s requirements under the EU Medical Device Regulation.
3. Importance for CE Mark Certification
This submission represents a critical regulatory milestone in Profusa’s strategy to secure CE Mark certification. Achieving CE Mark status is essential for the company’s plan to launch its continuous tissue oxygen monitoring technology in European markets.
4. Lumee Oxygen Platform Technology
The Lumee Oxygen Platform utilizes tissue-integrated biosensor technology to provide clinicians with continuous, real-time tissue oxygen data. The platform aims to address unmet clinical needs in tissue perfusion monitoring and support treatment decision-making.
