Search Tag: FDA clearance
2024 02 Oct
Abionic, an emerging medical diagnostics company focused on rapid early detection technologies, announced today that its IVD CAPSULE PSP test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to accelerate the Time-to-Detection of Sepsis. Already certified under the EU IVDR as of July 2022, this FDA clearance marks...Read more
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
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
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
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
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
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
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