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Masimo Gets FDA Nod for Sensor

Masimo Corp. (Nasdaq: MASI) received Food and Drug Administration approval for what it calls “a significant breakthrough in patient monitoring.”

Radius PPG is a tetherless sensor that permits patients to move throughout the hospital while still being continuously monitored. The measured data is displayed, via wireless connection, on other Masimo devices or third-party monitors.

The device is immediately available for approximately two million monitors around the world, the Irvine-based company said.

“Studies have shown that patient mobility is a key factor in more rapid patient recovery,” Masimo said in a statement. “In addition, the removal of cables has been shown to contribute to greater patient comfort, convenience, and patient satisfaction compared to tethered patient monitoring.”

Separately, the company announced last month the release of Halo ION after a decade of research.

The product is designed to provide a single warning score on a scale of zero to 100. It allows clinicians to aggregate trends from data points like pulse rates, oxygen saturation levels and electronic medical records. By allowing customized configuration, it enables clinicians to evaluate how patients are doing according to their own criteria.

“Precision medicine is no longer only about the right drug for the right patient based on their genetics, but also about individualized assessment of their state of health,” according to Masimo Chief Executive Joe Kiani.

Halo has the “unique ability to create patient-specific baselines and to take into account many subtle changes over time,” he said.

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