Search Tag: FDA clearance

ICU Management

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

ICU Management

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

ICU Management

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

ICU Management

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