www.fdanews.com/articles/175279-philips-scoops-up-clearance-for-expression-mr400
Philips Scoops Up Clearance for Expression MR400
February 10, 2016
The FDA has given Royal Philips 510(k) clearance for its Expression MR400, a new technology that monitors patients undergoing magnetic resonance imaging.
The product warns clinicians of severe medical changes and provides a comprehensive approach in monitoring the patients, the company said.
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. — Jonathon Shacat