Profusa, Inc. has received the ISO 13485:2016 certification from GMED, an EU MDR notified body, for its Lumee Oxygen Platform. This certification confirms that Profusa's quality management system meets international medical device standards, supporting ongoing conformity assessment under the EU Medical Device Regulation (MDR). The certification is a key milestone toward obtaining MDR certification and CE marking, which will allow Profusa to commercialize the Lumee Oxygen biosensor platform in Europe. The company can now begin manufacturing the device while continuing to work on remaining regulatory approvals.
Profusa's recent ISO 13485:2016 certification marks a significant regulatory milestone. For readers following the health sector, here is Pluang's market snapshot as of Oct 15, 2026 16:11 WIB: out of 150 priced US health stocks, 92 rose and 50 fell. Notable movers include Inovio Pharmaceuticals Inc (INO) with a 19.68% increase and a typical hold time of 43 days, Enveric Biosciences Inc (ENVB) down 12.41% with a 14-day hold, and BioNano Genomics Inc (BNGO) down 6.57% with a 50-day hold and 100% buy order activity.
TiDB, powered by PingCAP, announced new cloud platform capabilities to support enterprise and AI applications on a unified data foundation. Key updates include the upcoming general availability of TiDB Cloud Premium, public previews of Bring Your Own...
The Saudi Arabia Non-Invasive Prenatal Testing (NIPT) market is projected to grow from $52.5 million in 2025 to $162.16 million by 2034, at a CAGR of 13.35%. Growth is fueled by rising maternal age, advances in molecular diagnostics, and increased he...
ONEOK completed a $4.425 billion acquisition of Brazos Midstream's natural gas assets, doubling its processing capacity in the Permian Midland Basin to about 2.3 billion cubic feet per day. The deal secures 600,000 acres under long-term contracts, st...
Charles Schwab reported Q3 earnings per share of $1.69, beating estimates despite slightly missing revenue forecasts with $7.17 billion. The quarter marked a 17% revenue increase year-over-year and a 23% rise in net income to $2.91 billion, driven by...
Alcoa will release its Q3 2026 earnings on October 15, with analysts divided on earnings per share and revenue forecasts due to factors like rising aluminum sales, inventory changes, and higher input costs. The company expects a 54.9% jump in aluminu...
