Retia Medical secures 510(k) green light for its less-invasive cardiac output monitor

The FDA granted a 510(k) clearance to Retia Medical’s hemodynamic monitoring device for measuring a patient’s cardiac output in intensive care units or the operating room.

The Valhalla, New York-based company’s Argos monitor uses "multibeat analysis" algorithms and signal processing, which employ a blood pressure waveform derived from up to 20 heartbeats to produce a model of an adult patient’s circulation.

Retia says the monitor will help provide clinicians with accurate data to help track oxygen delivery and maintain the optimal fluid status in high-risk surgical and critically ill patients. In addition, the system integrates with current vital sign monitors and common electronic medical records platforms.

"A key challenge in realizing the potential clinical benefits of [cardiac output] monitoring is that many monitors fail to track CO changes accurately when fluid and vasoactive drug therapy are administered," said Marc Zemel, Retia’s co-founder and CEO. The company says its device and algorithms avoid the confounding effects that can cause inaccuracies in other hemodynamic monitors.

Because the Argos device connects directly to a vital sign monitor for information, eliminating the need for disposables with each use, Retia says the device can be much cheaper to own over a longer period of time compared to other hemodynamic monitoring systems. The company also hopes that this will help cardiac output monitoring become the standard of care for more patients in more settings, by reducing the cost and amount of work that has previously limited its use to the most high-risk patients.

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