Search Tag: FDA clearance

Masimo Get FDA Clearance of Pediatric Indication for SedLine® 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

Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment

2021 22 Dec

PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is authorized for emergency use in both high-risk adults and high-risk pediatric patients 12 years of age and older weighing at least 40 kg EUA based on clinical data from EPIC-HR study, showing PAXLOVID reduced risk of hospitalization or death by 89% (within three days of symptom... Read more

FDA Approves Delphinus 3D Whole Breast Ultrasound System

2021 16 Oct

The U.S. FDA recently granted PMA approval to Delphinus Medical Technologies’ SoftVue™ 3D Whole Breast Ultrasound Tomography System. This system is intended to supplement digital mammography for cancer screening women with dense breasts. About 40% of U.S. women have dense breast tissue, a risk factor for breast cancer. This risk is three-to-six times... Read more

Masimo Announces FDA 510(k) Clearance of Radius Tº™ 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 Recommends Against Reuse of Respirators

2021 12 Apr

The U.S. Food and Drug Administration (FDA) has released new recommendations regarding the use of disposable respirators suggesting “transition away from crisis capacity conservation strategies”.   You might also like: Two initiatives look into the options to safely reuse the masks and one connects hospitals with personal protective... Read more

FDA Clearance for Masimo O3® 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® 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