FDA clears Masimo’s Rainbow acoustic monitors for infants, neonates

Masimo (NSDQ:MASI) said today it won FDA clearance for its RAS-45 acoustic respiration sensor as part of its Rainbow Acoustic Monitoring system, cleared for use with infants and neonatal patients.

With the clearance, the Rainbow Acoustic Monitoring system is now cleared for use with patients of all sizes, the Irvine, Calif.-based company said. Previously, the system was only cleared for use with adult and pediatric patietns weighing greater than 10 kg, Masimo added.

The Rainbow Acoustic Monitoring system is designed to noninvasively and continuously measure respiration rates using an adhesive sensor with an integrated acoustic transducer applied to the patient’s neck, or for neonatal and infant patients, to the chest. The system separates and processes the respiratory signal to display continuous respiration rate and an acoustic respiration waveform, the company said.

“From the beginning, we have focused our R&D on neonates and children for many reasons, including our belief that helping clinicians care for children will provide more benefit to society. RAM harnesses the power of our breakthrough signal processing and sensor technology and applies it to a measurement that has either been unreliable or difficult to use, respiration measurement, the third vital sign,” founder & CEO Joe Kiani said in a press release.

Last month, Masimo released results from a study exploring the ability of the company’s Oxygen Reserve Index (ORi) to show trends in oxygenation during moderate hyperoxia.

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