Cardiovascular Intelligence Software Platform Granted FDA Clearance

Feb. 17, 2026 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Retia Medical's Argos Infinity, the company's cardiovascular intelligence software platform designed for high-risk surgical and critical care environments across health systems.

Agos Infinity builds on Retia's clinically validated Multi-Beat Analysis (MBA) algorithm and analyzes real-time physiologic data streams from existing monitoring and tele-ICU systems. By transforming routine signals into actionable cardiovascular insight, Argos Infinity supports earlier recognition of hemodynamic instability in operating rooms and intensive care units.

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).

Beginning with the 2026 reporting period, AKI is included as a hospital harm measure tied to reimbursement under CMS quality programs and will affect reimbursement in 2027.^1.  As hospitals face increasing accountability for preventable harm, earlier insight into cardiovascular instability becomes even more essential.

"In high-risk patients, deterioration can begin before traditional vital signs clearly reflect it," said Chiedozie Udeh, MD, MHEcon, MBA, FCCM, FASA, Professor of Anesthesiology and Medical Director, Cleveland Clinic eHospital. "By analyzing 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."

Delivering Consistent Hemodynamic Intelligence

"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 analyzes 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 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 United States, the Argos monitor is distributed by Medtronic plc.

To learn more about the company and and its products, go to retiamedical.com/

Reference

1. Centers for Medicare & Medicaid Services. Hospital Inpatient Quality Reporting Program — eCQM CMS832v3: Hospital Harm — Acute Kidney Injury. Available at: https://ecqi.healthit.gov/ecqm/hosp-inpt/2026/cms0832v3