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Masimo Announces FDA Clearance of the rainbow Acoustic Monitoring RAS-45 Sensor for Infant and Neonatal Patients
Sep. 10, 2018 09:03AM PST
Medical Device Investing
Masimo (NASDAQ:MASI) announced today FDA clearance of RAS-45, an acoustic respiration sensor for rainbow Acoustic Monitoring (RAM), for infant and neonatal patients. As quoted in the press release: 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 …
Masimo (NASDAQ:MASI) announced today FDA clearance of RAS-45, an acoustic respiration sensor for rainbow Acoustic Monitoring (RAM), for infant and neonatal patients.
As quoted in the press release:
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 respiration rate measurement is now, for the first time, possible for patients of all sizes, including neonates, in the United States.
RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, the RAS-45 and RAS-125c, applied to the patient’s neck area or, for infant and neonatal patients under 10 kg, the chest.
Using acoustic signal processing that leverages Masimo Signal Extraction Technology® (SET®), the respiratory signal is separated and processed to display continuous respiration rate (RRa®) and an acoustic respiration waveform, a visualization of the vibrations caused by the patient’s airflow. The acoustic sensor also allows clinicians to listen to the sound of a patient’s breathing, whether at the bedside, through a point-of-care device like the Radical-7® Pulse CO-Oximeter®, or remotely, from a Patient SafetyNet™ view station.
