FDA clears Siemens Healthineers blood analyzer
Siemens Healthineers (ETR: SHL) announced today that it won FDA clearance for its RapidPoint 500e blood gas analyzer for diagnosing and monitoring people in the intensive care unit, operating room or emergency room.
RapidPoint 500e is designed to generate blood gas, electrolyte, metabolite, CO-oximetry and neonatal bilirubin results that are then used to diagnose and monitor critically ill patients. The analyzer can be used in COVID-19 response efforts, where blood gas testing helps in managing infected patients and monitoring their respiratory distress.
Routine blood gas testing is also performed when patients need mechanical ventilation, according to a news release, which could further assist in the fight against coronavirus. RapidPoint 500e is already available in countries requiring CE Mark approval and can now aid in critical care testing as part of the coronavirus relief effort in the U.S.
The analyzer also uses Integri-sense technology to offer a series of automated functional checks designed to bring accurate results at the point of care. RapidPoint 500e is able to integrate into hospital networks with the Siemens Healthineers Point of Care Ecosystem for remote management of operators and devices across multiple sites.
“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,” Siemens Healthineers head of point of care diagnostics Christoph Pedain said in the news release. “A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important. 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.”