Heartfelt Technologies has announced that the FDA has granted Breakthrough Device Designation to the first-of-its-kind Heartfelt device, an AI-powered home monitoring technology designed to identify worsening heart failure before patients require hospital care.
The FDA Breakthrough Devices Program is reserved for medical technologies that have the potential to provide more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions.
The designation recognises Heartfelt’s potential to address a major unmet need in heart failure care by identifying worsening congestion before symptoms become severe, particularly in patients who struggle with traditional self-monitoring approaches.
Heart failure affects over 1 million people in the UK and remains one of the leading causes of avoidable hospital admissions. Many patients deteriorate gradually over days or weeks as fluid builds up in the body, but early warning signs are often missed because traditional monitoring relies on patients weighing themselves every day, recognising symptoms, or actively engaging with devices.
“As clinicians, we are always looking for solutions that work in the real world, not just in ideal circumstances. Many patients with heart failure find it difficult to maintain daily monitoring routines over long periods. The simplicity of a passive system that requires no behavioural change from patients is one of the aspects I find most compelling.” Dr Green, The Heart Center of Connecticut, USA.
“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. Daily weighing, symptom diaries, apps and wearable devices can all be effective, but maintaining engagement over months and years remains a major challenge in routine clinical practice, particularly for older, frail patients living with multiple health conditions. A passive monitoring approach that works automatically in the background has the potential to overcome these barriers and provide clinicians with earlier warning of deterioration.” said Dr Ameet Bakhai, Consultant Cardiologist, Royal Free London NHS Foundation Trust.
Heartfelt takes a different approach. Placed in the home, the Heartfelt device uses advanced imaging and AI to passively measure changes in foot and lower leg volume – a key indicator of fluid accumulation in heart failure. The system works automatically in the background without requiring patients to wear anything, remember to do anything, take measurements or change their daily routine.
Earlier studies demonstrated an average 13-day warning before worsening heart failure, while interim results from the HF-TRACK trial showed patients using the Heartfelt device experienced a 47% reduction in recurrent heart failure events.“This designation is an important moment for Heartfelt Technologies, but more importantly for heart failure patients,” said Dr Shamus Husheer, Co-Founder and CEO of Heartfelt Technologies.
“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.
The HF-TRACK results show that combining passive home monitoring with AI-based analysis can identify clinically meaningful changes early enough for clinical teams to successfully intervene, without requiring patients to wear devices or complete measurements. Interim study findings showed a 47% reduction in recurrent heart failure events compared with standard care, highlighting the potential impact of early detection and intervention.
This ability to continuously transform everyday observations into actionable clinical information represents a promising new direction for heart failure management.” said Dr Teresa Castiello, Consultant Cardiologist, Royal Free London NHS Foundation Trust.
Heartfelt’s technology introduces a new model of remote patient monitoring: moving from patient-dependent measurements to passive, continuous insight. The designation recognises the potential of this approach to address an important gap in heart failure care, particularly among elderly, frail and higher-risk patients who may have difficulty following long-term monitoring plans.
Clinical evidence supporting Heartfelt’s technology has demonstrated the potential impact of passive monitoring in identifying worsening heart failure earlier and helping clinicians intervene before patients require hospital care.
These results support Heartfelt’s vision of moving heart failure care from reactive treatment after a crisis occurs to proactive prevention; helping patients stay healthier at home and reducing the need for avoidable hospital admissions.
“The patients most at risk of hospitalisation are often the same patients who find daily monitoring the hardest. We created the Heartfelt device to remove that burden; technology that quietly looks after people in their own homes and alerts clinicians when they may need support. The most powerful part of this technology is not just that we can detect changes earlier; it is that we can do it without asking anything from patients,” said Dr Oriane Chausiaux Co-Founder and CSO of Heartfelt Technologies.
The company is actively recruiting patients into its FDA-approved IDE-B pivotal study, one of the largest studies of passive heart failure monitoring to date. Participating patients receive the Heartfelt device through CMS-funded remote patient monitoring programmes, while the study evaluates whether passive
AI-enabled monitoring can reduce heart failure events and improve outcomes. Complementary NIHR-funded studies continue to evaluate the technology within the NHS.
Breakthrough Device Designation provides Heartfelt Technologies with enhanced FDA interaction and priority review opportunities as it advances towards bringing its technology to patients and healthcare providers.
Dr Shamus Husheer, Co-Founder and CEO of Heartfelt Technologies said: “Heart failure care today is too often reactive and clinicians see patients after deterioration has already happened. Our goal is to give healthcare teams the opportunity to act earlier, keeping patients healthier at home and avoiding unnecessary hospital admissions. Many people living with heart failure are already managing multiple medications, appointments, symptoms and the day-to-day challenges of their condition.
“Asking them to take on yet another task every day is not always realistic. From the beginning, our goal was to create technology that quietly supports patients rather than placing additional demands on them. We believe passive monitoring has the potential to help more people stay well at home and avoid the disruption and distress of hospitalisation.
Receiving FDA Breakthrough Device Designation is a tremendous milestone for our company, and I am incredibly proud to see this vision recognised by the FDA. It is also a testament to the dedication, creativity and perseverance of our exceptional team, the support of our clinical collaborators, and the confidence our shareholders have placed in us throughout this journey. Most importantly, it reinforces our belief that we can make a meaningful difference to the lives of patients and families living with heart failure.”
