Profusa, Inc. (Nasdaq: PFSA) announced it has received an ISO 13485:2016 certificate from GMED, a notified body designated under the European Union Medical Device Regulation (MDR), according to a press release issued Oct. 15, 2026.

The certificate covers the design, development, and manufacture of the Lumee Oxygen tissue-integrated biosensors and associated readers at the company's Berkeley, California facility. The issuance follows a positive certification decision that Profusa announced on Sept. 24, 2026.

ISO 13485 is the internationally recognized standard for medical device quality management systems. The certification supports Profusa's ongoing MDR conformity assessment activities for the Lumee Oxygen Platform, which, if successfully completed, would support issuance of an MDR certificate and CE marking. CE marking would permit the company to pursue commercial distribution in the European Union, subject to applicable regulatory and operational requirements.

With the ISO certificate in hand, Profusa said it can now begin manufacturing the Lumee Oxygen Sensor Platform. The company stated it continues to work with GMED to complete remaining MDR conformity assessment activities.

The certification also aligns with the U.S. Food and Drug Administration's Quality Management System Regulation, which took effect Feb. 2, 2026, and incorporates ISO 13485:2016 by reference. The company noted the certification does not constitute FDA clearance or approval.

"This certification provides an important foundation as we continue working toward completion of our remaining MDR conformity assessment activities, obtaining MDR certification and CE marking, and preparing for future commercialization in Europe," said Ben Hwang, Ph.D., President of Profusa.

Profusa cautioned that there can be no assurance regarding the timing or outcome of remaining MDR conformity assessment activities, MDR certification, CE marking, or any market entry.