Yahoo · Oct 15, 2026
Profusa Receives ISO 13485:2016 Certificate from GMED
Providing a Foundational Quality Management System (QMS) for Commercialization Certificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announcedISO 13485 certification supports ongoing MDR conformity assessment activities for the Lumee Oxygen Platform and represents an important milestone toward MDR certification and CE marking. BERKELEY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA) ("Profusa" or the "Company"), a di

