AI Device Predicts Heart Failure 13 Days Early at Home

Heart failure patients may soon avoid emergency hospital visits thanks to a home device that watches over them automatically while they go about their daily lives.

Cambridge-based Heartfelt Technologies received FDA Breakthrough Device Designation for their first-of-its-kind AI monitoring system. The device sits in the home and uses advanced imaging to measure subtle changes in foot and lower leg swelling, a key sign that heart failure is getting worse.

The breakthrough is in what it doesn't require. Patients don't wear anything, don't take daily measurements, and don't change their routine at all. The system works silently in the background, analyzing changes and alerting doctors when intervention might prevent a crisis.

Heart failure affects over 1 million people in the UK alone and remains one of the leading causes of avoidable hospital admissions. Traditional monitoring asks patients to weigh themselves daily, track symptoms, or use wearable devices, but maintaining these routines over months and years proves difficult for many, especially elderly or frail patients living with multiple conditions.

Early studies showed the Heartfelt device provided an average 13-day warning before heart failure worsened. Interim results from the HF-TRACK trial revealed something even more promising: patients using the device experienced a 47% reduction in recurrent heart failure events compared to standard care.

Dr. Ameet Bakhai, Consultant Cardiologist at Royal Free London NHS Foundation Trust, explained the challenge. "One of the greatest challenges in heart failure care is that many of the patients at highest risk of hospitalisation are also the least able to engage with traditional monitoring programmes," he said. "A passive monitoring approach that works automatically in the background has the potential to overcome these barriers."

Dr. Shamus Husheer, Co-Founder and CEO of Heartfelt Technologies, emphasized that heart failure deterioration rarely happens overnight. "In many patients there is a period of progressive congestion and fluid accumulation before symptoms become severe enough to require hospital care," he said. The technology transforms everyday observations into actionable clinical information, giving care teams time to intervene successfully.

The Ripple Effect

The FDA Breakthrough Devices Program reserves its designation for technologies addressing life-threatening or irreversibly debilitating conditions. This recognition opens doors for faster development and review, potentially bringing passive monitoring to heart failure patients sooner.

The company is now recruiting patients into one of the largest studies of passive heart failure monitoring to date. Participating patients receive the device through CMS-funded remote patient monitoring programs while researchers evaluate whether this approach can reduce heart failure events and improve outcomes across diverse patient populations.

The shift from patient-dependent measurements to continuous, passive insight represents a new model for chronic disease management, one that meets patients where they are rather than asking them to change their lives around their condition.