Search Tag: FDA clearance
Masimo-get-fda-clearance-of-pediatric-indication-for-sedline-r-brain-function-monitoring-eeg-sensor
2022 28 Feb
SedLine's Advanced Depth of Anesthesia Monitoring Now Cleared for Use on Patients as Young as 1 Year Old in the United States Masimo has announced the FDA clearance of SedLine® brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. With this clearance, the potential benefits of SedLine have...Read more
Masimo-announces-fda-510-k-clearance-of-radius-totm-for-prescription-and-over-the-counter-otc-use
2021 21 Jun
The Radius Tº Wearable Continuous Body Temperature Thermometer Is Now Available for Use in Hospital and at Home Masimo announced today that Radius Tº™, a wearable, wireless thermometer that measures body temperature continuously and noninvasively, has received FDA 510(k) clearance for both prescription and over-the-counter (OTC) use on patients...Read more
Fda-clearance-for-masimo-o3-r-regional-oximetry-for-extended-use-in-cerebral-somatic-applications
2020 31 Aug
Masimo today announced that O3® Regional Oximetry has received FDA clearance for expanded use in monitoring somatic tissue oxygenation saturation in all patient populations and monitoring relative changes in hemoglobin, oxyhemoglobin, and deoxyhemoglobin in adult brains. With this FDA clearance, O3 is now indicated for use in both cerebral and somatic...Read more
Masimo-announces-fda-clearance-of-the-rainbow-acoustic-monitoring-r-ras-45-sensor
2018 10 Sep
Masimo announced today FDA clearance of RAS-45, an acoustic respiration sensor for rainbow Acoustic Monitoring® (RAM®), for infant and neonatal patients. RAM could previously be used to monitor adult and pediatric patients greater than 10 kg using RAS-125c and RAS-45 sensors. With clearance of the RAS-45 sensor for infant and neonatal patients, acoustic...Read more