Profusa Submits Responses to GMED for CE Mark Review of Oxygen Platform
Digital health company Profusa, Inc. has submitted a response package to its European Notified Body, GMED. The submission is part of the ongoing CE Mark review process for the Lumee® Oxygen Platform.
Profusa, Inc., a digital health company, has submitted a response package to GMED, its European Notified Body. This action is part of the conformity assessment process for the Lumee® Oxygen Platform's CE Mark certification under the Medical Device Regulation (MDR).
The company's submission includes updates to technical documentation, quality system evidence, clinical evaluation activities, and supporting validation information. This step is significant in Profusa's efforts to obtain CE Mark approval and advance the commercialization of the Lumee Oxygen Platform in Europe.
"Submitting our responses to GMED marks another meaningful milestone in the CE Mark review process," said Ben Hwang, Ph.D., Profusa’s Chairman and Chief Executive Officer. "We appreciate GMED's continued engagement throughout the assessment and remain committed to working collaboratively with the agency."
The Lumee Oxygen Platform aims to provide continuous, real-time tissue oxygen monitoring for clinicians. The CE Mark review process remains ongoing, and there is no certainty regarding the timing or outcome of GMED's assessment.