Profusa Secures Its ISO 13485:2016 Certificate From EU MDR Notified Body, GMED, Covering Lumee Oxygen Platform

Profusa, Inc. has received its ISO 13485:2016 certificate from GMED, an EU MDR notified body, for its Lumee Oxygen Platform, which includes tissue-integrated biosensors and associated readers. This certification is a crucial milestone for the company's ongoing conformity assessment activities under the EU Medical Device Regulation and is expected to facilitate commercial distribution in the European Union. The certificate confirms that Profusa's quality management system meets international standards for medical devices.