U.S. FDA Clearance for Retia Medical’s Argos Cardiac Output Patient Monitor

Hemodynamic Monitoring company Retia Medical, LLC, tells us that its Argos Cardiac Output (CO) Monitor has received U.S. FDA 510k clearance and is now available for sale in the United States.

Background

The Argos CO monitoring device is intended to be used as a hemodynamic monitor for cardiac output monitoring and its derived parameters on patients over 18 years of age in the intensive care unit or the operating room.

Accurate CO monitoring can dramatically improve proactive clinical decision-making for high-risk surgical and critically ill patients and improves operating room (OR) and intensive care unit (ICU) outcomes. The Argos CO Monitor provides clinicians with the data required to track oxygen delivery and maintain optimal fluid status. Additionally, by eliminating disposable costs and integrating seamlessly with all vital signs monitors and common electronic medical record (EMR) systems, the Argos CO Monitor provides a simple and cost-effective solution to making CO monitoring broadly accessible in a greater number of care settings and making CO monitoring a standard of care for more patients.

Equipped with Retia’s proprietary Multi-Beat Analysis™ (MBA™) algorithm, which uses advanced signal processing to improve the model of circulation and enables accurate tracking of both fluid and pressor resuscitation, the Argos Monitor seamlessly combines accuracy, ease of use, EMR connectivity and cost-effectiveness.

Company comments

“A key challenge in realizing 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,” said Marc Zemel, S.M., M.B.A., co-founder and Chief Executive Officer of Retia Medical. “We designed Retia’s proprietary MBA™ algorithm to overcome the limitations of current CO monitoring technologies in order to realize the potentially life-saving benefits that accurate and effective hemodynamic management can provide to patients. With FDA clearance, the Argos CO Monitor is now available for sale in the United States and we are excited for the opportunity to advance CO monitoring as a strategy for improving patient outcomes.”
Source: Globe Newswire

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