Masimo wins CE Mark for O3 pediatric indication

Masimo (NSDQ:MASI) said today it won CE Mark approval for a pediatric indication on its O3 regional oximetry with the O3 pediatric sensor.

The O3 regional oxymetry system uses near-infared spectroscopy to monitor absolute and trended regional tissue oxygen saturation in the cerebral region, which can detect imbalances in oxygen delivery. The new indication clears the use of the O3 sensor for pediatric patients less than 88 lbs.

“O3 regional oximetry provides access to valuable data about cerebral oxygen saturation, and studies have shown that the risks of cerebral desaturations include neurological injury2,3, increased length of hospital stays3, increased time on mechanical ventilation4, and other adverse outcomes5. With adult trend accuracy of 3% and absolute accuracy of 4% without controlling CO2, and trend accuracy of 3% in pediatric patients6, Masimo O3 should help clinicians build a better picture of brain oxygenation – and hopefully better outcomes for all of their patients, including pediatric ones,” CEO Joe Kiani said in a press release.

The O3 regional oxymetry system has FDA 510(k) clearance for adults over 88lbs, but is not cleared for use in pediatric patients, and the O3 pediatric sensor is not currently for sale in the U.S.

Earlier today, Masimo released 2nd quarter earnings that topped the street and send shares skyward in early morning trading.

The Irvine, Calif.-based company reported profits of $30 million, or 57¢ per share, on sales of $164.6 million for the 3 months ended July 2. The company topped expectations from Wall Street, who were looking for earnings per share of 40¢ and revenue of $163.6 million.

Shares surged in early morning trading after the release, up 9.3% to trade at $58.11 as of 9:38 a.m. EDT.

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