Chicago, Ill. — Cardiosense has announced the publication of results from its SEISMIC-HF I study, marking a significant step forward in noninvasive heart failure monitoring. The study, now available in the Journal of the American College of Cardiology: Heart Failure, shows that the company’s wearable sensor and machine learning algorithm can estimate cardiac filling pressure with accuracy comparable to that of implanted devices.
The study focused on pulmonary capillary wedge pressure (PCWP), a key measurement in assessing heart function, particularly in patients with heart failure with reduced ejection fraction (HFrEF). Traditionally, PCWP is obtained through invasive procedures or implantable monitors, which are costly and carry risks. Cardiosense’s technology instead uses a chest-worn device—the CardioTag—to collect seismocardiogram, electrocardiogram, and photoplethysmogram signals, which are then processed by an AI model to estimate pressure levels.
Conducted across 15 U.S. centers, the SEISMIC-HF I study included 310 participants undergoing right heart catheterization, the current gold standard for measuring PCWP. Researchers found that the wearable solution provided pressure estimates on par with implantable sensors and performed consistently across sex, race, ethnicity, and body types.
Dr. Liviu Klein of UCSF, the study’s lead author, called the findings “a critical advancement” in making hemodynamic-guided care more accessible. “We know this type of monitoring reduces hospital readmissions and mortality,” Klein said. “But widespread use has been limited by invasiveness and cost. This study points to a safer, scalable solution.”
The results were previously highlighted as late-breaking science at the American Heart Association’s 2024 Scientific Sessions. Cardiosense’s chief scientific officer, Dr. Omer Inan, said the publication reflects more than a decade of collaborative research across medicine, data science, and engineering.
With the validation of this noninvasive method, Cardiosense is positioning its AI-powered platform as a potential tool to reshape how clinicians manage heart failure—making advanced monitoring available outside of specialized centers and to a broader patient population.