Profusa, Inc., a digital health technology company, develops bioengineered sensors for body to detect and continuously transmit clinical-grade data for personal and medical use in the United States. It offers the Lumee Oxygen Platform to monitor compromised tissue for peripheral artery disease, chronic wounds, and reconstructive surgery. The company researches and develops the Lumee Glucose Platform which is designed to monitor glucose levels in interstitial fluid. Profusa, Inc. is based in Berkeley, California.
Profusa Announces Significant Progress Towards Lumee® Oxygen Platform CE Mark with ISO 13485 Certification Expected in Early October
Profusa received a positive decision from notified body GMED on ISO 13485 certification of its quality management system, a key step toward European CE marking of the Lumee Oxygen Platform.
Certification is expected in early October, after which the company must still complete remaining MDR conformity assessment activities before the CE mark can be issued.
The company cautions there is no assurance on the timing or outcome of the remaining assessments, so the milestone advances but does not guarantee the European launch path.