FDA Breakthrough Designation Granted to Coredio’s AI-Powered Heart Failure Monitoring Platform

The U.S. Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to Coredio’s Cardiac Performance Simulation Engine (CPSE) and accepted the platform into the its Total Product Life Cycle Advisory Program (TAP).

CPSE is a software-only platform designed to deliver catheterization-comparable heart failure (HF) hemodynamic assessment using consumer smartwatches and standard blood pressure cuffs in clinical and home settings under physician supervision.

“We’re proud that Coredio has been granted FDA Breakthrough Device Designation and is enrolled in TAP,” Coredio Co-Founder/Chief Technology Officer Mehdi Mortazawy said. “CPSE fuses a physics-based digital twin of the cardiovascular system with advanced AI to noninvasively classify the four hemodynamic parameters central to HF management. These designations from FDA reflect the scientific rigor 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.”

Coredio is now on an accelerated, priority path toward FDA 510(k) submission. For many HF patients, the most vulnerable period begins when they leave the hospital. Clinicians often lose visibility into cardiac decompensation until symptoms become severe enough to trigger another emergency room visit or hospital readmission.

“Heart failure management has long been limited by the gap between what we can measure in the hospital and what we can reliably understand once patients return home,” stated Dr. Jagmeet P. Singh, M.D., Ph.D., Mass General Brigham. “Coredio’s approach, using wearable-derived signals and physics-informed AI to estimate hemodynamic status noninvasively, has the potential to give clinicians a more holistic view of patient cardiac function and enable earlier intervention.”

Heart failure is the most expensive problem in American medicine. It affects more than 6.7 million people and is a leading cause of hospitalization in adults older than 65, yet the cardiac hemodynamic data clinicians rely on most to guide treatment are concentrated in settings where patients spend the least time. Cardiac catheterization, the clinical gold standard, is invasive and performed in only ~10% of patients. Echocardiography is primarily limited to hospital settings, while implantable hemodynamic sensors are reserved for the highest-risk patients. CPSE is device-agnostic and designed to help close this gap by bringing hemodynamic assessment into the home and physician office using wearables patients already own.

CPSE is a software-only platform with proprietary algorithms designed to identify abnormal status across four key hemodynamic parameters used by cardiologists to assess whether HF patients are stable or deteriorating. These include left ventricular end-diastolic pressure (LVEDP), central venous pressure (CVP), systemic vascular resistance (SVR), and cardiac index (CI), enabling a more holistic view of both left- and right-sided HF.

“At White Plains Hospital, our transitional care program focuses on the critical weeks after discharge, when heart failure patients are most vulnerable and least connected to their care team,” commented Dr. Farrukh Jafri, M.D., White Plains Hospital. “What drew us to Coredio is its potential to bring hemodynamic-level data into that gap, without requiring invasive devices or additional clinical visits.”

CPSE pairs a physics-based digital twin of a patient’s cardiovascular system with machine learning trained on clinical data. After an initial personalization step, patients use a smartwatch and standard blood pressure cuff for on-demand indication of hemodynamic status for clinician review.

“Heart failure management has long been limited by the gap between what we can assess invasively or with imaging tools and what we can see at home,” noted Dr. Jennifer Monti, a cardiologist with SSM Health. “Coredio’s approach, extracting catheterization-comparable hemodynamic data from consumer wearables using physics-based AI, has the potential to close that gap and give clinicians the visibility they need to intervene earlier and make more informed decisions for heart failure patients.”

Founded in 2023, Coredio is a digital artificial intelligence (AI) health company developing non-invasive, advanced, and intelligent hemodynamic assessment technology for HF care. Its CPSE uses a personalized physics-based digital twin of the cardiovascular system and machine learning models trained on proprietary clinical data to identify abnormal hemodynamic status across four key intracardiac parameters, using only consumer wearables and blood pressure cuffs. Coredio’s platform is intended to support clinician assessment in clinical and home settings.