Profusa Receives ISO 13485:2016 Certificate from GMED
Key Highlights
- ➤Profusa (PFSA) receives ISO 13485:2016 certificate from GMED
- ➤Certificate covers Lumee Oxygen biosensors and associated readers
- ➤Certification supports ongoing MDR conformity assessment for Lumee Oxygen Platform
- ➤Profusa can now begin manufacturing the Lumee Oxygen Sensor Platform
- ➤CE marking and European commercial distribution remain subject to further requirements
Expert Statements
Ben Hwang, President of Profusa
“Obtaining ISO 13485 certification provides potential customers, partners, and interested physicians with independent confirmation that Profusa's quality management system conforms to an internationally recognized medical device standard. 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”
Providing a Foundational Quality Management System (QMS) for Commercialization * Certificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announced * ISO 13485 certification supports ongoing MDR conformity assessment activities for the Lumee Oxygen Platform and represents an important milestone toward MDR certification and CE marking. BERKELEY, Calif., Oct. 15, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (Nasdaq: PFSA) ("Profusa" or the "Company"), a digital health company pioneering next-generation biosensor technologies, today announced that it has received its ISO 13485:2016 certificate from GMED, a notified body designated under the European Union Medical Device Regulation (MDR). The certificate covers the design, development and manufacture of the Lumee Oxygen tissue-integrated biosensors and associated readers (the Lumee Oxygen Platform) at the Company's Berkeley, California facility. Its issuance follows the positive certification decision Profusa announced on September 24, 2026.
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