Masimo wins FDA nod for pediatric O3 regional oximetry indication

Masimo (NSDQ:MASI) said today it won FDA 510(k) clearance for a pediatric indication for O3 regional oximetry with its O3 pediatric sensor.

With the extended indication, the Irvine, Calif.-based said that O3 regional oximetry monitoring will be available for pediatric patients which weigh more than 11lbs and less than 88lbs.

The technology works by using near-infared spectroscopy to continuously monitor absolute and trended regional tissue oxygen saturation in the cerebral region.

“O3 regional oximetry provides access to valuable data about cerebral oxygen saturation. With adult and pediatric trend accuracy of 3% and absolute accuracy of 4% and 5% on adults and pediatrics respectively, without controlling CO2, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatrics as young as three-months old,” CEO & founder Joe Kiani said in a prepared statement.

Earlier this month, Masimo said it launched the Early Warning Score system for the Root patient monitoring and connectivity hub.

The EWS system is designed to aggregate information from multiple vital signs and clinical observations to determine the potential degree of patient deterioration, the company said.

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