Friday, Royal Philips said that it has received Food and Drug Administration clearance for IntelliVue Guardian, a monitoring system that detects subtle signs of impending health issues for hospitalized patients. The 510(k) clearance allows the global company to pair IntelliVue Guardian with the single-use, adhesive Philips Wearable Sensor in the U.S.
The software acquired CE Mark certification for sale in Europe in October.
“This little biosensor is the gap filler” that facilitates continuous monitoring of heart rate and respiration in high-acuity patients, said Dr. Kevin Dellsperger, CMO of Augusta (Georgia) University Health. Dellsperger was one of several participants in a Philips-sponsored breakfast discussion Monday at the annual Healthcare Information and Management Systems Society conference in Orlando, Florida.
In a pilot at Augusta University Medical Center, IntelliVue Guardian regularly was able to head off cardiac arrest and found an 88 percent reduction in “predictable” codes, Dellsperger reported.
“We found that…