FDA grants breakthrough designation to Coredio heart failure assessment platform

Coredio said the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Cardiac Performance Simulation Engine, or CPSE, a software platform designed to assess heart failure hemodynamics using consumer smartwatches and standard blood pressure cuffs.

The company also said the FDA accepted the platform into its Total Product Life Cycle Advisory Program, known as TAP, placing the technology on an accelerated path toward a future 510(k) submission.

Coredio, founded in 2023, is developing software intended to provide catheterization-comparable hemodynamic assessment without invasive procedures. The company said the platform is designed for use in clinical and home settings under physician supervision.

Heart failure affects more than 6.7 million people in the United States and remains a leading cause of hospitalization among adults older than 65. Clinicians often rely on invasive cardiac catheterization or hospital-based imaging to evaluate hemodynamic status, limiting their ability to monitor patients after discharge.

Coredio said its software-only platform uses proprietary algorithms to identify abnormal status across four hemodynamic parameters commonly used in heart failure management: left ventricular end-diastolic pressure, central venous pressure, systemic vascular resistance and cardiac index.

The company said CPSE combines a physics-based digital twin of a patient’s cardiovascular system with machine learning models trained on clinical data. After an initial personalization step, patients can use a smartwatch and blood pressure cuff to generate on-demand hemodynamic assessments for clinician review.

Jagmeet P. Singh of Mass General Brigham said the technology could help clinicians better monitor patients after they leave the hospital.

“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,” Singh said in a statement.

Farrukh Jafri of White Plains Hospital said the technology could help bridge a monitoring gap during the weeks following hospital discharge.

“What drew us to Coredio is its potential to bring hemodynamic-level data into that gap, without requiring invasive devices or additional clinical visits,” Jafri said.

Jennifer Monti, a cardiologist at SSM Health, said the platform could improve clinicians’ visibility into patients’ conditions at home and support earlier intervention.

Mehdi Mortazawy, co-founder and chief technology officer of Coredio, said the FDA designations recognize both the unmet need in heart failure management and the company’s scientific approach.