• Profusa received a positive decision from GMED on ISO 13485 certification for its quality management system.
• Certification is expected in early October as part of the Lumee Oxygen Platform CE mark process under the EU MDR.
• GMED’s remaining MDR conformity assessment steps could still affect the timing of the MDR certificate and CE marking.

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 GlobeNewswire (Ref. ID: 202609240730PRIMZONEFULLFEED9833086) on September 24, 2026, and is solely responsible for the information contained therein.