Heartfelt device granted Breakthrough Device Designation by FDA
Tue, Jun 23, 2026
The contactless, passive monitoring technology is designed to identify worsening heart failure before patients require hospital care.
The FDA 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.
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.
