Profusa Receives ISO 13485 Certification From GMED

Profusa received ISO 13485:2016 certification from GMED, enabling manufacturing of its Lumee Oxygen Platform. Remaining EU medical device conformity assessments are ongoing; MDR certification and CE marking are still pending. 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 (Ref. ID: 202610150630PRIMZONEFULLFEED9846217) on October 15, 2026, and is solely responsible for the information contained therein. (C)