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. CoreDio’s approach, using wearable-derived signals and physics-informed AI to estimate hemodynamic status noninvasively, has the potential to give clinicians a more continuous view of patient physiology and enable earlier intervention. The FDA Breakthrough Device Designation is an important recognition of the clinical need this technology is aiming to address.

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. What drew us to Coredio is its potential to bring hemodynamic-level data into that gap — without requiring invasive devices or additional clinical visits. A smartwatch and blood pressure cuff that can approximate catheterization-level data in the home setting could meaningfully change how we monitor and respond to early decompensation. We are studying this through a longitudinal home monitoring protocol, and the FDA’s Breakthrough Device Designation strengthens our confidence that this is a technology worth rigorously evaluating.

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. 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 real-time visibility they need to intervene earlier and make better evidence-based decisions for CHF patients. The FDA’s Breakthrough Device Designation is well-deserved recognition of how transformational this technology could be for our patients - both in heart failure and in any disease classification where hemodynamic assessment impacts outcomes

As a heart failure cardiologist taking care of patients with complex and dynamic heart failure syndromes, it is often that patients don’t get enough attention in between outpatient visits. Coredio is a novel platform, employing digital twin approach to extrapolate catheterization-comparable hemodynamic data, such as filling pressures, cardiac index, and systemic vascular resistance, from wearable devices. As such Coredio’s platform is uniquely positioned to address the residual risk gap between visits that patients face. The FDA’s Breakthrough Device Designation and TAP Pilot acceptance is an exciting development for the platform and reflect the potential impact of this non-invasive monitoring approach.