AI-powered platform uses consumer wearables to help clinicians monitor heart failure patients beyond the hospital
SANTA CLARA, Calif.–(BUSINESS WIRE)–Coredio, a digital health company developing the first software-as-a-medical-device (SaMD) platform dedicated to heart failure (HF) hemodynamic assessment, today announced that the U.S. Food and Drug Administration has granted its Cardiac Performance Simulation Engine (CPSE™) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheterization-comparable hemodynamic assessment using consumer smartwatches and standard blood pressure cuffs in clinical and home settings under physician supervision.
Coredio is now on an accelerated, priority path toward 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 ER 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,” 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.”
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 over 65, yet the cardiac hemodynamic data clinicians rely on most to guide treatment is 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,” 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.”
CPSE™ pairs a physics-based digital twin of the 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,” 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.”
For more information on Coredio and to request a demo of Coredio’s CPSE platform, visit https://www.coredio-ai.com/.
ABOUT COREDIO
Founded in 2023, Coredio is a digital AI health company developing noninvasive advanced and intelligent hemodynamic assessment technology for heart failure care. Its Cardiac Performance Simulation Engine (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 only using consumer wearables and blood pressure cuffs. Coredio’s platform is intended to support clinician assessment in clinical and home settings. Coredio’s CPSE™ received FDA Breakthrough Device Designation under Q242872/S001 in March 2026. FDA BDD does not constitute FDA approval or clearance. For more information, visit https://www.coredio-ai.com/.
Contacts
Yashar Seyed Vahedein ([email protected])
