Coredio’s haemodynamic heart failure (HF) assessment software has obtained breakthrough device designation from the US Food and Drug Administration (FDA).
The California-based digital health company’s cardiac performance simulation engine (CPSE) is designed to provide clinicians with a means to assess HF patients once they have been discharged from the hospital, a period in which patients are often less connected to their care teams, which is widely viewed as the most vulnerable time following HF.
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Research indicates that following an episode of decompensation, approximately 30% of patients hospitalised with HF are readmitted within three months of discharge, with mortality during this period approaching 10%.
Coredio’s software as a medical device (SaMD) identifies abnormal status across the haemodynamic parameters of 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 of cardiac catheterisation, Coredio stated.
Following an initial personalisation step in which patients’ baseline measurements are taken using protocols such as an electrocardiogram (ECG), Coredio’s CPSE uses artificial intelligence (AI) to create a ‘digital twin’ of a patient’s cardiovascular system. From there, wearables and standard blood pressure cuffs can be used to obtain ‘on-demand’ indication of haemodynamic status for clinician review.
Along with breakthrough designation, CPSE has also been accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP), a voluntary pilot by the Center for Devices and Radiological Health (CDRH) that is designed to accelerate patient access to innovative medical devices.
Mehdi Mortazawy, Coredio’s co-founder and chief technology officer, commented: “These designations from the FDA reflect the scientific rigour and the urgency of the unmet need in HF management and how Coredio is poised to help cardiology specialists and their patients meet this need in the future.”
GlobalData analysis reveals that the global patient monitoring market is forecast to reach a valuation of around $25.9bn in 2035. Other companies using remote patient monitoring (RPM) tools for HF include Noah Labs, which received FDA breakthrough designation in March 2026 for its tool that analyses voice recordings to detect worsening patient HF rates.
HF is the prevalent cause of hospital admission globally. The condition affects approximately six million Americans, with prevalence projected to increase by 46% and direct medical costs to reach $53bn by 2030.
