Profusa Inc., a California-based developer of tissue-integrated biosensor technology, has received ISO 13485 certification for its quality management system from GMED, a notified body under the European Union Medical Device Regulation (MDR). The certification marks a milestone in the company’s efforts to meet regulatory standards for its Lumee Oxygen Platform, a device designed to provide continuous, real-time monitoring of tissue oxygen levels via biosensors embedded in tissue. This data supports clinicians in making treatment decisions and patient monitoring, according to Profusa’s description. The platform is positioned as a potential advancement in precision medicine and critical care monitoring.
The ISO 13485 certification follows a positive decision from GMED, though Profusa notes that additional MDR conformity assessments remain pending. Successful completion of these activities would enable the issuance of the necessary MDR certificate and the subsequent CE marking, which would allow the Lumee Oxygen Platform to be sold across the 27 EU member states. The CE mark is a prerequisite for market access in the EU, ensuring compliance with stringent safety, health, and environmental protection standards. Profusa has not provided a specific timeline for the completion of these remaining assessments or the timing of the CE marking.
The certification aligns with Profusa’s broader strategy to expand its medical device portfolio. Earlier this year, the company announced an option agreement to acquire G3 Vision Labs Inc. and its subsidiaries, a move that could further position Profusa in the growing market for advanced diagnostic and monitoring technologies. Ben Hwang, president of Profusa, expressed satisfaction with the progress made in strengthening the company’s quality management system, emphasizing the alignment with GMED’s requirements and the significance of the ISO 13485 certification.
While the certification is a positive development, it does not guarantee the final regulatory approval or market launch timeline. Profusa continues to collaborate with GMED to address outstanding MDR conformity assessments, a process that could extend beyond the current timeline. The achievement underscores the company’s commitment to regulatory compliance and innovation in medical device technology, though regulatory hurdles remain a critical factor in its path to commercialization.
