Yahoo · Sep 24, 2026
Profusa ISO 13485 Certification Decision Advances Lumee Oxygen Platform Toward CE Mark
Profusa received a positive decision from GMED on ISO 13485 certification, expected in early October, while additional European MDR conformity assessment work remains before the Lumee Oxygen Platform can receive a CE mark. Key Investor TakeawaysProfusa (NASDAQ:PFSA) received a positive decision from notified body GMED regarding certification of its quality management system to ISO 13485.

