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

operating room
Retia hopes its Argos system will help make cardiac output monitoring the standard for more patients in more settings. (Pixabay)

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.

Webinar

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.
The Argos system. (Retia Medical)

“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.

RELATED: Retia Medical pulls in $7M Series A round

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.

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Novartis unveiled more data showing how its asthma combo QMF149 fared against the standard of care: a combination of the same types of drugs.

Johns Hopkins researchers developed a biodegradable polymer to transport large therapies into cells—including genes and even CRISPR.