FDA issued Emergency Use Authorization for Philips’ acute care patient monitoring solutions for hospitals

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On Jul. 2, 2020, Royal Philips announced that the U.S. Food and Drug Administration (FDA) had issued an Emergency Use Authorization (EUA) for Philips’ IntelliVue Patient Monitors MX750/MX850 and its IntelliVue Active Displays AD75/AD85, for use in the US during the COVID-19 health emergency. These patient monitoring solutions support infection-control protocols and remotely provide critical patient information for caregivers, capabilities that are much needed when caring for hospitalized COVID-19 patients.

Philips’ IntelliVue Patient Monitors MX750/MX850 and IntelliVue Active Displays AD75/AD85 received CE mark in 2019 and are already being used in hospitals across Europe. The EUA allows Philips to start delivering the new remote patient monitoring solution to hospitals in the US, and the company is committed to submitting a 510(k) to FDA for this acute care solution in the course of 2020. 

As countries across the globe continue to combat COVID-19, while gradually resuming elective care, Philips is significantly increasing its patient monitor production to address the demand for increased Intensive Care Unit (ICU) capacity. Hospitals and health systems are increasingly relying on health technology to better manage the influx of COVID-19 patients they are seeing in Emergency Rooms (ERs) and ICUs. To minimize staff exposure to the virus that causes COVID-19 while still delivering quality care, there is a critical need for patient monitors that enable clinicians to remotely monitor a patient’s condition.

The IntelliVue Patient Monitors MX750/MX850 and IntelliVue Active Displays AD75/AD85 offer advanced functionality and clinical decision support capabilities such as Philips’ IntelliVue Horizon Trends information view, which shows deviations in vital signs (for example, CO2 and heart rate) to contextualize a patient’s condition, while also supporting infection-control protocols and access to key information both remotely and at the bedside. Features such as Philips’ Alarm Advisor and Alarm Reporting help to reduce alarm fatigue for caregivers, while the smooth glass surfaces, rounded edges and special surface material of the monitors and displays facilitates cleaning and disinfection.

The MX750 and MX850 monitors are the latest additions to Philips’ portfolio of integrated patient monitoring solutions to support improved clinical and operational workflows. The MX750 and MX850 also include updated features, including enhancements to monitor and assess clinical and network device performance, and additional functionalities to strengthen cybersecurity. 

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Source: Royal Philips
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