Coredio's AI Gets FDA Nod to Fight Heart Failure at Home

SANTA CLARA, CA – May 28, 2026 – A novel artificial intelligence platform that uses data from consumer smartwatches to monitor heart failure patients at home has received a significant boost from U.S. regulators, signaling a potential paradigm shift in managing one of America's costliest medical conditions.

Digital health startup Coredio announced its Cardiac Performance Simulation Engine (CPSE™) has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration. The software-as-a-medical-device (SaMD) was also accepted into the FDA's Total Product Life Cycle Advisory Program (TAP), putting it on an accelerated path toward market clearance.

The technology aims to solve a critical and dangerous problem in cardiology: the lack of visibility into a patient's condition after they leave the hospital. By using signals from a standard smartwatch and blood pressure cuff, Coredio’s platform promises to deliver a level of hemodynamic assessment previously only available through invasive procedures, empowering doctors to intervene before a patient's condition deteriorates into a crisis.

Beyond the Hospital Walls: Closing the Care Gap

Heart failure affects over 6.7 million Americans and is a leading cause of hospitalization for adults over 65. The total cost of care is projected to exceed $70 billion by 2030, with hospital readmissions driving a majority of the expense. For many patients, the most vulnerable period begins the moment they are discharged.

“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 of Mass General Brigham in a statement.

This "care gap" is what Coredio is designed to close. Clinicians often lose insight into a patient's cardiac decompensation until symptoms become severe, often resulting in an emergency room visit or another costly hospitalization. Coredio’s platform is intended to provide a continuous, non-invasive window into the patient's cardiac function from the comfort of their home.

The system is designed to alert clinicians to subtle, subclinical changes that may indicate a worsening condition. “What drew us to Coredio is its potential to bring hemodynamic-level data into that gap, without requiring invasive devices or additional clinical visits,” noted Dr. Farrukh Jafri of White Plains Hospital, highlighting the platform's role in transitional care programs focused on the critical weeks post-discharge.

By identifying patients at risk of deterioration earlier, the technology holds the potential to not only reduce the staggering rate of hospital readmissions but also significantly improve the quality of life for millions living with this chronic condition.

The Science of a Digital Heart

At the core of Coredio’s innovation is a sophisticated fusion of physics and artificial intelligence. The CPSE™ platform creates a personalized, physics-based "digital twin" of each patient's cardiovascular system. This virtual model is calibrated using the patient's own data and then paired with machine learning algorithms trained on extensive clinical datasets.

After an initial personalization step, a patient can perform on-demand assessments using two common devices: a consumer smartwatch and a standard blood pressure cuff. The software analyzes the data streams from these devices to non-invasively estimate four key hemodynamic parameters that cardiologists use to manage heart failure:

• Left ventricular end-diastolic pressure (LVEDP): A measure of pressure in the heart's main pumping chamber before it contracts, indicating how "full" the heart is.
• Central venous pressure (CVP): An indicator of fluid status and right-sided heart function.
• Systemic vascular resistance (SVR): The resistance the heart must pump against to circulate blood.
• Cardiac index (CI): A measure of the heart's pumping performance relative to body size.

Historically, obtaining this comprehensive hemodynamic profile required invasive cardiac catheterization, a procedure performed on only about 10% of heart failure patients due to its risks and costs. Coredio claims its software can provide "catheterization-comparable" insights. While a bold claim, the company is currently conducting validation studies against this invasive gold standard at partner sites in the U.S. to substantiate its performance for the FDA.

“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,” said Dr. Jennifer Monti, a cardiologist at SSM Health.

Navigating the Regulatory Fast Track

Receiving FDA Breakthrough Device Designation is more than just an accolade; it is a critical accelerator for technologies addressing life-threatening conditions with no approved alternatives or that offer significant advantages over existing ones. This designation provides Coredio with prioritized review and more frequent, collaborative communication with the FDA, which can significantly reduce the time and uncertainty of the regulatory process.

Further bolstering its position is its acceptance into the FDA's new Total Product Life Cycle Advisory Program (TAP). Launched in 2023, the TAP pilot is designed to provide proactive strategic advice from the FDA and other stakeholders to help innovative devices navigate the path from development to market more efficiently. For Coredio, this means a more streamlined journey toward a 510(k) submission, the most common pathway to market for medical devices.

“We’re proud that Coredio has been granted FDA Breakthrough Device Designation and is enrolled in TAP,” said Mehdi Mortazawy, Co-Founder & CTO of Coredio. “These designations from FDA reflect the scientific rigor and the urgency of the unmet need in HF management.”

This dual regulatory endorsement not only validates the potential clinical impact of the CPSE™ platform but also sends a strong signal to investors and the broader medical community about the technology's promise and the company's progress.

The Digital Health Frontier and Data Integrity

Coredio enters a dynamic but crowded digital health landscape. Its approach is distinct from both highly invasive implantable monitors, like Abbott's CardioMEMS which is reserved for the sickest patients, and general-purpose remote patient monitoring (RPM) platforms that typically track simpler metrics like weight and blood pressure. Coredio’s unique value proposition lies in its ability to extract sophisticated hemodynamic data non-invasively, using hardware that many patients already own.

However, handling such sensitive medical data generated from consumer devices raises critical questions about data security and privacy. As a Software as a Medical Device, the CPSE™ platform will be required to meet the stringent security and privacy standards of the Health Insurance Portability and Accountability Act (HIPAA).

This involves implementing robust technical safeguards like end-to-end encryption for data in transit and at rest, secure access controls, and regular vulnerability assessments. The company must ensure that patient data is protected from unauthorized access or breaches at every step, from the smartwatch to the clinician's dashboard. Gaining and maintaining the trust of both patients and healthcare providers will be paramount to the platform's adoption and success. The close collaboration with the FDA through the Breakthrough and TAP programs inherently includes rigorous scrutiny of these cybersecurity and data integrity plans, providing a structured framework to ensure the platform is not only effective but also secure.