Philips secures 510(k) clearance to market new patient monitoring solution to bring bedside quality monitoring to the MR suite
February 10, 2016
Expression MR400 warns clinicians of severe medical changes and provides comprehensive approach in monitoring patients undergoing MR imaging
ANDOVER, MA. –Royal Philips (NYSE: PHG AEX: PHIA) today announced the Expression MR400, a new technology that monitors patients undergoing magnetic resonance imaging (MRIs), has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The MR400 provides 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.
“When a patient is under anesthesia, it’s incredibly important to keep a close eye on their condition so that clinicians can intervene early to prevent any complications. Clinicians often compare monitoring anesthetized patients in the MR suite to piloting a plane in the fog with limited instrumentation,” said Carla Kriwet, CEO of Philips Patient Care and Monitoring Solutions. “The MR400 gives clinicians comparable detail to patient monitors in the ICU and other wings of the hospital, providing them with increased confidence on the condition of their patients.”
Raising quality of patient monitoring in the MR Suite 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 MR400 monitors the same vital signs that are tracked in the operating room and in the intensive care unit, including heart rate, oxygen and carbon dioxide levels, body and surface temperatures, and blood pressure, and also includes advanced 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 touchscreen with the same interface as other Philips’ monitors, making it easier for clinicians to view and respond to patient data.
Connecting data across the healthcare ecosystem The MR400 expands Philips commitment to working with healthcare systems to create innovative connected health solutions. 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, ensuring that all care team members have access to the same high quality patient information.
The Expression MR400 builds on the Philips line of MR patient monitoring solutions, which are used in each of the top 10 children’s hospitals in the U.S. For more information on Philips full suite of patient monitoring solutions, visit www.philips.com/monitoring.
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2014 sales of EUR 21.4 billion and employs approximately 104,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.
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