Profusa Receives ISO 13485 Certification for Medical Device Platform
News related to:Profusa · 2 min read
BERKELEY, Calif., Oct. 15, 2026 /CourierPR/ -- Profusa, a digital health company pioneering next-generation biosensor technologies, has received its ISO 13485:2016 certificate from GMED, an EU MDR notified body. The certificate covers the design, development, and manufacture of the Lumee Oxygen tissue-integrated biosensors and associated readers, which are part of the Lumee Oxygen Platform. This certification follows the positive certification decision previously announced by Profusa on September 24, 2026.
ISO 13485 is the internationally recognized standard for medical device quality management systems. Profusa's ISO 13485:2016 certification demonstrates, through independent audit, that the company's quality management system conforms to the applicable requirements of the standard within the scope of certification. This certification is a significant step supporting the company's ongoing conformity assessment activities for the Lumee Oxygen Platform, which is a crucial component of the company's strategy to obtain MDR certification and CE marking.
The Lumee Oxygen Platform is designed to provide continuous, real-time monitoring of tissue oxygen levels through Profusa's proprietary tissue-integrated biosensor technology. The platform is intended to provide clinicians with objective tissue perfusion data that may support treatment decision-making and patient monitoring.
ISO 13485 certification is also commonly expected of medical device suppliers during European hospital procurement and distributor qualification processes. With the ISO certificate in hand, Profusa can now begin manufacturing the Lumee Oxygen Sensor Platform. The company continues to work with GMED to complete the remaining conformity assessment activities for the Lumee Oxygen Platform, which, if successfully completed, would support the issuance of the MDR certificate and CE marking. This certification would allow Profusa to pursue commercial distribution in the European Union, subject to satisfying applicable regulatory and operational requirements.
Profusa's ISO 13485:2016 certification provides potential customers, partners, and interested physicians with independent confirmation that the company's quality management system conforms to an internationally recognized medical device standard. This certification provides an important foundation as Profusa continues to work toward completion of its remaining MDR conformity assessment activities, obtaining MDR certification and CE marking, and preparing for future commercialization in Europe.
The Litigation Reform Act of 1995 refers to the United States Private Securities Litigation Reform Act of 1995, which provides a safe harbor for forward-looking statements. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa, including statements regarding the proposed acquisition of G3, and Profusa's strategic plans. These statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain.
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 Profusa continues to work toward completion of its remaining MDR conformity assessment activities, obtaining MDR certification and CE marking, and preparing for future commercialization in Europe.
With the ISO certificate in hand, Profusa can now begin manufacturing the Lumee Oxygen Sensor Platform, and the company continues to work with GMED to complete the remaining conformity assessment activities for the Lumee Oxygen Platform. With ISO 13485 certification, Profusa can now pursue commercial distribution in the European Union, subject to satisfying applicable regulatory and operational requirements.