Masimo SafetyNet Opioid System gets marketing authorisation from FDA

Masimo SafetyNet Opioid System gets marketing authorisation from FDA

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Medical technology company Masimo has received marketing authorisation from the US Food and Drug Administration (FDA) for its SafetyNet Opioid System, an anti-opioid-overdosing device.

Approved for individuals aged 15 and older, the Masimo SafetyNet Opioid System is suitable for use in hospitals or at home to safeguard individuals taking prescribed opioid medications or using opioids illegitimately.

The SafetyNet Opioid system is a monitoring device designed to help identify life-threatening opioid overdose in individuals before it causes major harm or even death.

The device responds to potential opioid-induced respiratory depression (OIRD) in an individual caused by opioid use or overdose. The response takes the form of a series of escalating notifications to the device user as well as personal emergency contacts.

The notification action will ensure that the patient receives the appropriate treatment intervention, for example naloxone.

Masimo SafetyNet is a scalable and cloud-based patient management platform that enables clinical-grade spot-checking and continuous measurements. It also comprises digital care pathways and remote patient surveillance capabilities.

Last December, Masimo announced the limited market launch of an early warning indicator called Sepsis Index (Si).

Si uses aggregated data from Patient SafetyNet to provide early warning of possible sepsis or other causes of deterioration in a patient’s condition.

The Patient SafetyNet system integrates real-time physiological data from Masimo and third-party bedside monitoring equipment to create displays that are shown at central stations.

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