Profusa Announces Significant Progress Towards Lumee® Oxygen Platform CE Mark with ISO 13485 Certification Expected in Early October

Barchart · 1d ago

BERKELEY, CA, Sept. 24, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA), a digital health company pioneering next-generation biosensor technologies today announced that the Company has received a positive decision from GMED regarding certification of its quality management system to ISO 13485. GMED is a notified body designated under the European Union Medical Device Regulation (MDR). The Company continues to work with GMED toward completion of the remaining applicable MDR conformity assessment activities for the Lumee® Oxygen Platform. Successful completion of these activities would support issuance of the applicable MDR certificate and the Company's subsequent CE marking of the Lumee Oxygen Platform. The CE mark signifies that a product sold within the 27 EU member states meets high safety, health and environmental protection standards.

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