Profusa submits response package to GMED in Lumee Oxygen Platform CE mark review

Profusa, Inc.

Profusa, Inc.

PFSA

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  • Profusa submitted its response package to notified body GMED in its ongoing MDR conformity assessment for CE Marking of the Lumee Oxygen Platform.
  • The filing follows completion of GMED’s Stage 1 and Stage 2 assessments of Profusa’s quality system and technical documentation.
  • Review remains ongoing with no assurance on timing or outcome of the CE Mark decision.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Profusa Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202606120800PRIMZONEFULLFEED9745891) on June 12, 2026, and is solely responsible for the information contained therein.

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