Heartfelt receives FDA Breakthrough Device Designation
The device offers passive, non-contact monitoring for early heart failure event detection, reducing events by 47% in studies.
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AI-powered non-contact telemonitoring for heart failure patients
hftech.orgLast updated
In short: Heartfelt Technologies secured FDA Breakthrough Device Designation for its AI-powered heart failure monitoring system and expanded trials.
The device offers passive, non-contact monitoring for early heart failure event detection, reducing events by 47% in studies.
The study shows the Heartfelt Device detects heart failure changes up to 13 days in advance. It thanks NHS collaborators.
The installation supports the FDA-approved HEARTFELT Study for 1,600 patients, with remote monitoring by Connect America at The Heart Center CT.
The pilot demonstrates reliable AI-enabled monitoring for heart failure patients in community settings, reducing readmission risks without added burden. The team seeks US research partners at HFSA ASM2025.
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