SANTA CLARA, Calif. — Coredio said the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Cardiac Performance Simulation Engine, an AI-powered software platform designed to help clinicians assess heart failure patients outside the hospital.
The Santa Clara-based digital health company said the platform, known as CPSE, has also been accepted into the FDA’s Total Product Life Cycle Advisory Program. Coredio said the software-only platform is designed to provide catheterization-comparable hemodynamic assessment using consumer smartwatches and standard blood pressure cuffs in clinical and home settings under physician supervision.
The company said CPSE is now on an accelerated, priority path toward a 510(k) submission.
“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,” said Dr. Jagmeet P. Singh, MD, PhD, 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.”
Coredio said heart failure affects more than 6.7 million people and is a leading cause of hospitalization among adults over 65. The company said many patients are most vulnerable after leaving the hospital, when clinicians often have limited visibility into worsening cardiac function until symptoms become severe enough to require emergency care or readmission.
The company said cardiac catheterization remains the clinical gold standard for hemodynamic assessment but is invasive and performed in only about 10% of patients. Echocardiography is primarily limited to hospital settings, while implantable hemodynamic sensors are generally used for the highest-risk patients.
Coredio said CPSE is designed to help close that gap by bringing hemodynamic assessment into the home and physician office using wearables patients may already own.
The platform uses proprietary algorithms to identify abnormal status across four hemodynamic parameters used by cardiologists to assess whether heart failure patients are stable or deteriorating. Those parameters include left ventricular end-diastolic pressure, central venous pressure, systemic vascular resistance and cardiac index.
“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,” said Dr. Farrukh Jafri, MD, 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.”
Coredio said 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 to generate on-demand indications 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,” said Dr. Jennifer Monti, Cardiologist, 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.”
“We’re proud that Coredio has been granted FDA Breakthrough Device Designation and is enrolled in TAP,” said Mehdi Mortazawy, Co-Founder & CTO, Coredio. “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.”
