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Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee® Oxygen Platform

GlobeNewswire Inc.·
Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee® Oxygen Platform

Profusa has submitted a comprehensive response package to its European Notified Body GMED following successful completion of Stage 1 and Stage 2 assessments for CE Mark certification of its Lumee Oxygen Platform. The submission includes updates to technical documentation, quality system evidence, clinical evaluation activities, and validation information. The company remains committed to obtaining CE Mark certification to support European commercialization of its tissue oxygen monitoring technology.

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