Medical device manufacturer Retia Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) to market its Argos Cardiac Output (CO) monitor.
Argos is a hemodynamic monitor designed for tracking cardiac output and its derived parameters on patients in an intensive care unit (ICU) or operating room (OR).
The monitoring device provides the data necessary to monitor oxygen delivery and maintain optimal fluid status.
It uses the company’s Multi-Beat Analysis (MBA) Algorithm that uses advanced signal processing for accurate tracking of fluid and pressor resuscitation.
The monitor is only suitable for use on patients aged 18 or over.
Retia Medical co-founder and CEO Marc Zemel said: “A key challenge in realising the potential clinical benefits of CO monitoring is that many monitors fail to track CO changes accurately when fluid and vasoactive drug therapy are administered.
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“We designed Retia’s proprietary MBA algorithm to overcome the limitations of current CO monitoring technologies in order to realise the potentially life-saving benefits that accurate and effective hemodynamic management can provide to patients.”
The device is designed to improve proactive clinical decision-making in cases of high-risk surgical and critically ill patients. Improvements can enhance outcomes in ICU and OR.
Argos is said to be a simple and cost-effective solution as it avoids disposable costs. The device can be easily integrated with all vital signs monitors and common electronic medical record (EMR) systems.
It features an intuitive user interface, along with instant access to patients’ hemodynamic profiles from remote locations. The monitor can be adopted in a variety of care settings.