A certificate lets Profusa start making sensors that track oxygen in body tissue.
Profusa, Inc. (PFSA) received ISO 13485:2016 certification from GMED, a step toward MDR certification and CE marking for its Lumee Oxygen Platform. The certification covers the design, development, and manufacture of the platform at its Berkeley facility. Profusa aims to begin manufacturing the platform and pursue commercial distribution in the EU, subject to regulatory approvals.
