Edwards gets FDA clearance for hemodynamic monitoring platform
US-based Edwards Lifesciences has obtained clearance from the US Food and Drug Administration (FDA) for its hemodynamic monitoring platform, HemoSphere.
The advanced platform is designed to enable timely decisions by providing clarity to clinicians on the hemodynamics or the blood flow factors of a patient.
It is claimed that the scalable monitoring platform can be customised according to the requirements of each patient and clinician.
Edwards Lifesciences critical care corporate vice-president Catherine Szyman said: "The HemoSphere advanced monitor builds on Edwards' more than 50 years of experience in providing clinicians with technology and education to help improve patient care and lays the foundation for future advancements in hemodynamic monitoring."
The platform's wireless advanced monitor can be used to collect and evaluate the hemodynamic data of a patient and is compatible with the Edwards Swan-Ganz pulmonary artery catheter and oximetry catheters.
Loma Linda University Medical Center clinical research and perioperative ultrasound director Davinder Ramsingh said: "The HemoSphere advanced monitor enables simplified visual clinical support, which is particularly important in the care of our most complex, critically ill patients.
"Clinicians can choose the clinical support screens that best suit their needs and monitor the pressures and blood flow of the heart as conditions change, informing potentially life-saving decisions on behalf of their patients."
HemoSphere also features visual clinical support screens and an intuitive touchscreen that allow clinicians to tailor the platform according to the needs of their care environment.
The HemoSphere advanced monitor has been approved for commercialisation in Europe, Japan, Australia and New Zealand.