Profusa receives ISO 13485 certification for Lumee Oxygen Platform

FREE Breaking News Alerts from StreetInsider.com!

E-mail Address

StreetInsider.com Top Tickers, 10/21/2026

1. SPCX
2. NVDA
3. NFLX
4. ISRG
5. TSLA
6. META
7. RTX
8. SMCI
9. GOOGL
10. S

Go back to Profusa receives ISO 13485 certification for Lumee Oxygen Platform

Profusa Receives ISO 13485:2016 Certificate from GMED

October 15, 2026 6:30 AM EDT

                   Providing a Foundational Quality Management System (QMS) for Commercialization

Certificate issued by GMED, an EU MDR notified body, following the positive certification decision previously announcedISO 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... More