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Siemens Healthineers Receives FDA Clearance for Blood Gas Analyzer

NEW YORK – Siemens Healthineers said Tuesday it has received US Food and Drug Administration clearance for its RapidPoint 500e Blood Gas Analyzer, which is used to monitor critically ill patients, including those with COVID-19, in acute care settings.

The analyzer is now available in the US, as well as in Europe and countries requiring the CE mark where it was launched in August 2019, the firm said.

Siemens Healthineers' analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room. 

"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," Christoph Pedain, head of point-of-care diagnostics at Siemens Healthineers, said in a statement. 

The analyzer supports COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress, the firm said.

Routine blood-gas testing is 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.

Erlangen, Germany-based Siemens Healthineers said that its analyzer consists of Integri-sense Technology, a series of automated functional checks designed to deliver accurate test results at the point-of-care.

Additionally, the analyzer integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers remote management of operators and devices located across multiple sites, the firm said.