FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Clears Masimo’s Cerebral Oxygenation Monitor for Neonates

June 11, 2019

The FDA granted Masimo additional 510(k) clearance for its O3 Regional Oximetry platform for monitoring brain oxygen levels in neonatal patients.

The O3 sensors use near-infrared spectroscopy to monitor the hemoglobin oxygen saturation of blood on both sides of the brain. Because neonatal pathology is often brain-related, the sensors  may be “particularly helpful” in providing insight into neonatal patient status, the company said.

The sensors are now available in a smaller size and flexible design, allowing them to fit comfortably on the foreheads of neonatal patients that weigh less than 22 pounds.

View today's stories