Profusa Submits Response Package to GMED as Part of Ongoing CE Mark Review Process for Lumee® Oxygen Platform
BERKELEY, CA, June 12, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensing technologies, today announces that it has submitted its response package to questions received from its European Notified Body, GMED, following the successful completion of the Stage 1 and Stage 2 quality system and technical documentation assessments conducted by GMED as part of the MDR conformity assessment process for the Lumee® Oxygen Platform.
BERKELEY, CA, June 12, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensing technologies, today announces that it has submitted its response package to questions received from its European Notified Body, GMED, following the successful completion of the Stage 1 and Stage 2 quality system and technical documentation assessments conducted by GMED as part of the MDR conformity assessment process for the Lumee® Oxygen Platform.
Summary aggregated from GlobeNewswire's public RSS feed. The full reporting belongs to GlobeNewswire — please read it on their site.