FDA clears Siemens Healthineers RAPIDPoint 500e blood gas analyzer used for critically ill patients

April 1, 2020

Siemens Healthineers announced that its latest critical care testing solution, the RAPIDPoint 500e blood gas analyzer, has received clearance from the U.S. Food and Drug Administration. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room or emergency room. Already available in countries requiring the CE mark, the RAPIDPoint 500e blood gas analyzer is now available for critical care testing in the United States.

“Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers. “The RAPIDPoint 500e blood gas analyzer has become a trusted instrument in Europe’s endeavor to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients.”

The RAPIDPoint 500e blood gas analyzer is an essential instrument supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation. Arterial blood gas tests provide the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required.

A key feature of the analyzer is Integri-sense technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. The RAPIDPoint 500e blood gas analyzer also integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers convenient, remote management of operators and devices located across multiple sites.

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