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Cardiac output monitoring device receives FDA clearance
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Retia Medical announced that a cardiac output monitoring device for patients who are at high surgical risk or critically ill and in the ICU or operating room has received 510(k) clearance from the FDA and is now available for sale in the United States.
The cardiac output monitoring device (Argos Cardiac Output Monitor) is a hemodynamic monitor that tracks oxygen delivery and allows clinicians to maintain optimal fluid status, according to a press release from the company.
“A key challenge in realizing the potential clinical benefits of [cardiac output] monitoring is that many monitors fail to track [cardiac output] changes accurately when fluid and vasoactive drug therapy are administered,” said Marc Zemel, SM, MBA, co-founder and CEO of Retia Medical, said in the press release. “We designed Retia’s proprietary [Multi-Beat Analysis] algorithm to overcome the limitations of current [cardiac output] monitoring technologies in order to realize the potentially lifesaving benefits that accurate and effective hemodynamic management can provide to patients.”
The device features an algorithm that improves the quality and accuracy of cardiac output monitoring. In addition, the device can connect to a vital signs monitor by one cable, allowing it to obtain info on BP signals, and can be integrated to electronic medical record systems, according to the press release.
Disclosure: Zemel is an employee of Retia Medical.