Medical technology company Getinge reported on Friday the receipt of US Food and Drug Administration (FDA) 510(k) clearance for its PulsioFlex Monitoring System and PiCCO Module for advanced bedside monitoring in hospitals for critically ill patients.

Part of the company's Maquet brand, the PulsioFlex Monitoring System is a diagnostic aid used to measure and monitor blood pressure and cardiopulmonary, circulatory and organ function variables in patients in intensive care units (ICUs).

Additionally, the company's PiCCO Module is used for hemodynamic management of critically ill patients. It provides cardiac output measurement based on pulse contour analysis and intermittently through transpulmonary thermodilution technique.

According to the company, the PulsioFlex Monitoring System is a flexible platform for advanced hemodynamic monitoring that can be adapted to each patient's individual needs at any time. It can be configured to support HIPAA compliance. It has a modular setup that easily allows for future technology integration. with the PulsioFlex monitor, the number of PiCCO parameters has been expanded by four – from nine to 13.

Getinge added that its PulsioFlex monitoring system allows real-time dynamic monitoring with a dedicated PiCCO module, which is the only system in the US that continuously measures cardiac and pulmonary values including CPI, ELWI and GEDI for the critically ill patient.