Coredio’s CPSE Platform for HF Assessment Gains FDA Breakthrough Designation

May 28, 2026—Coredio, a digital health company developing a software-as-a-medical-device platform dedicated to heart failure hemodynamic assessment, announced that the FDA has granted Breakthrough Device designation to the company’s Cardiac Performance Simulation Engine (CPSE).

Additionally, the FDA has accepted the CPSE platform into its Total Product Life Cycle Advisory Program (TAP). Coredio is now on an accelerated, priority path toward an FDA 510(k) submission, noted the press release.

Coredio stated that 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.

The company explained that 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.

CPSE is a software-only platform with the company’s algorithms designed to identify abnormal status across the four key hemodynamic parameters used to assess whether HF patients are stable or deteriorating: left ventricular end-diastolic pressure; central venous pressure; systemic vascular resistance; and cardiac index.

Coredio noted that CPSE is device-agnostic and designed to bring hemodynamic assessment into the home and physician office using wearables that patients already own.

“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,” commented Jagmeet P. Singh, MD, in the company press release. “Coredio’s approach, using wearable-derived signals and physics-informed artificial intelligence to estimate hemodynamic status noninvasively, has the potential to give clinicians a more holistic view of patient cardiac function and enable earlier intervention.”