Royal Philips (NYSE:PHG) said today it won FDA 510(k) clearance for its Expression MR400 monitor designed for patients undergoing magnetic resonance imaging.
The MR400 is designed to provide ICU-comparable bedside monitoring for all patients, including those with serious medical conditions or those who require anesthesia, in the MR Suite.
“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. 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,” Philips patient care and monitoring solutions CEO Carla Kriwet said in prepared remarks.
Due to the strong electromagnetic fields in the MR suite, it is not possible to use traditional patient monitors without complications or degradation of images, according to Philips. The lack of appropriate monitoring can put patients at risk as clinicians may not be able to identify if a patient is in distress.
The MR400 monitors heart rate, oxygen and carbon dioxide levels, body and surface temperatures, blood pressure and allows for advanced ECG monitoring. The device includes alarms for desaturation, apnea and extreme bradycardia and tachycardia, Philips said.
In late January, Philips reported rising sales and profits for its healthcare division during both the 4th quarter and full-year 2015.
The Dutch conglomerate, which is looking to deal its legacy lighting business and its Lumileds LED operation, said Philips Healthcare reported sales growth of 14.8% to $3.54 billion (€3.27 billion) for the 3 months ended Dec. 31, 2015. Adjusted earnings before interest, taxes and amortization grew 22.6% for the quarter, to $559.0 million (€516.0 million) compared with Q4 2014.
For the full year, Philips Healthcare reported sales growth of 18.8% to $11.82 billion (€10.91 billion) and adjusted EBITA growth of 17.0%, to $2.43 billion (€2.24 billion) compared with 2014.
