Retia Medical has announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for Argos Infinity, the company’s cardiovascular intelligence software platform designed for high-risk surgical and critical care environments across health systems.
Argos Infinity builds on Retia’s clinically validated Multi-Beat Analysis (MBA) algorithm and analyses real-time physiologic data streams from existing monitoring and tele-intensive care unit (ICU) systems. By transforming routine signals into actionable cardiovascular insight, Argos Infinity supports earlier recognition of haemodynamic instability in operating rooms and ICUs, the company says in a press release.
High-risk patients often begin to deteriorate before changes appear in standard vital signs. In cardiac surgery patients, nearly 70% of low cardiac index time occurs while blood pressure remains normal. Delayed recognition can drive ICU escalation and organ injury, including acute kidney injury (AKI).
“In high-risk patients, deterioration can begin before traditional vital signs clearly reflect it,” said Chiedozie Udeh, professor of anaesthesiology and medical director, Cleveland Clinic eHospital. “By analysing the monitoring data we already collect, Argos Infinity expands visibility into patients’ cardiovascular status across surgical settings and critical care units without requiring additional bedside hardware.”
“FDA clearance of Argos Infinity marks an important step in extending reliable cardiovascular insight beyond individual devices and into the broader digital care environment,” said Marc Zemel, chief executive officer of Retia Medical. “Hospitals already collect vast amounts of physiologic data. Infinity analyses those existing data streams to deliver consistent hemodynamic intelligence across operating rooms and intensive care units, without requiring replacement of current monitoring infrastructure.”
Argos Infinity has been deployed under institutional review board (IRB) approval across more than 400 beds in multi-hospital tele-ICU environments, where it operates on top of existing digital monitoring platforms. With FDA clearance, Retia can now expand that deployment. The software applies Retia’s Multi-Beat Analysis algorithm, which has been validated in 14 peer-reviewed clinical publications and shown to perform reliably in complex conditions including arrhythmia, low cardiac output states, and unstable blood pressure.
Argos Infinity complements Retia’s Argos cardiac output monitor, extending the same patented algorithmic foundation from the bedside to high-risk surgical and critical care environments across health systems. In the USA, the Argos monitor is distributed by Medtronic.
