FDA Clears Retia Medical's Argos Infinity Software for Networked Cardiac Output Monitoring

The U.S. Food and Drug Administration has cleared Argos Infinity, software from Retia Medical that calculates a patient's cardiac output and related hemodynamic measures from arterial blood pressure data already flowing across a hospital network, Xtalks reported on February 19. The product is aimed at operating rooms, ICUs and remote tele-ICU settings.

The FDA's 510(k) database lists Argos Infinity (Rev. 1.0) as K253092, a traditional 510(k) from Retia Medical Systems, Inc. of White Plains, New York, received on September 23, 2025 and found substantially equivalent on February 13, 2026. It is classified under product code DXG.

Same algorithm, new deployment

According to the 510(k) summary, Argos Infinity is software as a medical device installed on a server inside the hospital's network. A waveform source, such as the data aggregator used for central monitoring in an ICU, sends it 20 seconds of invasive blood pressure waveform at a time, and the software returns cardiac output, stroke volume, systemic vascular resistance, their indexed values and pulse pressure variation. A third-party application then pulls the results into the patient's medical record.

The predicate is Retia's own Argos bedside monitor (K181372). The summary says the algorithm is identical to the one in that device, with no changes to signal processing or calculation methods, and that the differences are limited to the operating environment and deployment model, including support for remote and central command-center monitoring.

The cleared indication covers adults 18 and older who have radial arterial blood pressure catheters, for use by clinicians at the bedside or in remote settings in the operating room or ICU. Clinical validation used Philips IntelliVue and GE CARESCAPE monitors, and the summary says compatibility claims are limited to those configurations.

For the comparison with the predicate, Retia used archived recordings from 40 OR and ICU patients and found that Argos Infinity met pre-set equivalence criteria of 0.1 L/min or 6%, the summary says.

Prior use and company claims

Retia said the underlying Multi-Beat Analysis algorithm has been evaluated in 14 peer-reviewed publications, and that before clearance the software ran under institutional review board approval across more than 400 beds in multi-hospital tele-ICU settings, Xtalks reported. The company also said that in cardiac surgery patients nearly 70% of low cardiac index time occurs while blood pressure is in the normal range.

Retia said the clearance lets it expand use of Argos Infinity beyond research settings. Its bedside Argos Cardiac Output Monitor is distributed in the U.S. by Medtronic, according to Xtalks.