Technology | Patient Monitors | February 11, 2016

Philips Secures FDA 510(k) Clearance for New MRI Patient Monitor

Expression MR400 warns clinicians of severe medical changes and provides comprehensive approach in monitoring patients undergoing MRI

Philips, FDA 510k clearance, Expression MR400, MRI patient monitor

February 11, 2016 — Royal Philips announced U.S. Food and Drug Administration (FDA) 510(k) clearance for the Expression MR400, a new technology that monitors patients undergoing magnetic resonance imaging (MRI). The MR400 provides intensive care unit (ICU)-comparable, bedside-quality monitoring in the MR suite for all patients, including those with serious medical conditions or who require anesthesia.

In the MR suite, strong electromagnetic fields make it impossible for clinicians to use traditional patient monitors without causing complications with the monitor or degradation of the images. The lack of adequate monitoring is particularly problematic for patients, including children, who require anesthesia when getting an MRI. Without the ability to reliably track key vital signs, clinicians may not know a patient is in distress until it is too late. 

The MR400 is designed not to create image artifacts or other interference from the electromagnetic fields when used according to the labeling, ensuring that patients receive the level of clinical care and monitoring they need. The device monitors the same vital signs that are tracked in the operating room and in the ICU, including heart rate, oxygen and carbon dioxide levels, body and surface temperatures, and blood pressure, and also includes advanced electrocardiogram (ECG) monitoring. Patients with serious medical conditions, including critical care patients or patients undergoing cardiac procedures, can also be monitored with the MR400, regardless of whether they are under anesthesia.

Similar to traditional patient monitors, the MR400 uses intelligent alarms to warn clinicians of severe patient changes, including desaturation, apnea and extreme bradycardia/tachycardia. Clinicians and staff are able to customize the monitor settings for each patient to prioritize warning signals to reduce alarm fatigue. The new monitoring system uses a touch screen with the same interface as other Philips monitors, making it easier for clinicians to view and respond to patient data. 

The MR400 uses wireless technology, connects with the electronic healthcare record and shares information with IntelliBridge Enterprise to seamlessly send and receive patient information across the hospital. This ensures that all care team members have access to the same high-quality patient information.

For more information: www.philips.com

Related Content

An example of a coronary computed tomography angiography (CCTA) exam. The CIAO study looked at patients who have a problem of blood flow limitation and chest pain symptoms in the absence of a 50 percent or more artery narrowing, known as ischemia with no obstructive CAD, or INOCA.

An example of a coronary computed tomography angiography (CCTA) exam. The CIAO study looked at patients who have a problem of blood flow limitation and chest pain symptoms in the absence of a 50 percent or more artery narrowing, known as ischemia with no obstructive CAD, or INOCA.

News | Cardiac Imaging | April 03, 2020
April 3, 2020 — Patients who experience chest pain and have abnormal results on a cardiac stress test but who do not
Schematic depiction of the automated process for assessing fat, muscle, liver, aortic calcification, and bone from original abdominal CT scan data

Figure 1: Depiction of the fully automated CT biomarkers tools used in this study. (A) Schematic depiction of the automated process for assessing fat, muscle, liver, aortic calcification, and bone from original abdominal CT scan data. (B) Case example in an asymptomatic 52-year-old man undergoing CT for colorectal cancer screening. At the time of CT screening, he had a body-mass index of 27·3 and Framingham risk score of 5% (low risk). However, several CT-based metabolic markers were indicative of underlying disease. Multivariate Cox model prediction based on these three CT-based results put the risk of cardiovascular event at 19% within 2 years, at 40% within 5 years, and at 67% within 10 years, and the risk of death at 4% within 2 years, 11% within 5 years, and 27% within 10 years. At longitudinal clinical follow-up, the patient suffered an acute myocardial infarction 3 years after this initial CT and died 12 years after CT at the age of 64 years. (C) Contrast-enhanced CT performed 7 months before death for minor trauma was interpreted as negative but does show significant progression of vascular calcification, visceral fat, and hepatic steatosis. HU=Hounsfield units.

News | Cardiac Imaging | March 06, 2020
March 6, 2020 — Researchers at the National Institutes of Health a
ASNC Announces Multisocietal Cardiac Amyloidosis Imaging Consensus
News | Cardiac Imaging | September 09, 2019
The American Society of Nuclear Cardiology (ASNC) published a new expert consensus document along with eight other...
Philips Debuts Cardiac Ultrasound and Enterprise Informatics Offerings at ESC 2019
News | Cardiac Imaging | August 30, 2019
Philips will showcase its latest cardiac care innovations at the European Society of Cardiology (ESC) Congress 2019,...
A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse

Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers.

News | Cardiac Imaging | June 07, 2019
The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular...
At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve).

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve). Photo by Greg Freiherr

Feature | Cardiac Imaging | March 22, 2019 | By Greg Freiherr
Reflecting a trend toward the increased use of ...
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.

SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram. Results from an international study presented at #ACC19 show that pressure readings in coronary arteries may identify locations of stenoses remaining after cardiac cath interventions.

Feature | Cardiac Imaging | March 18, 2019 | By Greg Freiherr
As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the
Overlay Init