Coredio’s hemodynamic heart failure (HF) assessment software has received breakthrough device designation from the U.S. Food and Drug Administration (FDA).
The California-based digital health company’s Cardiac Performance Simulation Engine (CPSE) is designed to give clinicians a way to assess heart failure patients after they are discharged from the hospital. This period is widely considered to be the most vulnerable period after heart failure, as patients are often less connected to their care team.
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Studies have shown that approximately 30% of patients hospitalized with heart failure after an episode of decompensation are readmitted within 3 months of discharge, with mortality rates approaching 10% during this period.
Coredio’s Software as a Medical Device (SaMD) identifies abnormal conditions across hemodynamic parameters such as left ventricular end-diastolic pressure (LVEDP), central venous pressure (CVP), systemic vascular resistance (SVR), and cardiac index (CI), providing HF assessment comparable to the clinical gold standard for cardiac catheterization, Coredio said.
Following an initial personalization step that uses protocols such as an electrocardiogram (ECG) to take baseline patient measurements, Coredio’s CPSE uses artificial intelligence (AI) to create a “digital twin” of the patient’s cardiovascular system. From there, wearables and standard blood pressure cuffs can be used to obtain an “on-demand” indication of hemodynamic status for clinician review.
In addition to the Breakthrough designation, CPSE was also accepted into FDA’s Total Product Life Cycle Advisory Program (TAP), a voluntary pilot by the Center for Devices and Radiological Health (CDRH) aimed at facilitating patient access to innovative medical devices.
Mehdi Mortazawy, co-founder and chief technology officer of Coredio, commented, “These designations from the FDA reflect the scientific rigor and urgency of the unmet need in heart failure management and how Coredio stands ready to help cardiologists and their patients meet this need in the future.”
According to GlobalData analysis, the global patient monitoring market is expected to reach a valuation of approximately $25.9 billion in 2035. Other companies using remote patient monitoring (RPM) tools for heart failure include Noah Labs, which received FDA Breakthrough designation in March 2026 for a tool that analyzes audio recordings to detect worsening heart failure rates in patients.
Heart failure is a common cause of hospitalization worldwide. The disease affects approximately 6 million Americans, prevalence is expected to increase by 46%, and direct medical costs are projected to reach $53 billion by 2030.
