Chicago-based medical technology startup Cardiosense has received U.S. Food and Drug Administration clearance for the first-of-its-kind non-invasive device that can measure heart pressure without requiring catheterization, a development that could transform how physicians monitor heart failure patients.
The FDA granted the company’s de novo classification request, a regulatory pathway reserved for novel medical devices that have no existing predicate. The clearance means Cardiosense can now market the device commercially, positioning it as a less invasive alternative to the standard procedure of inserting a catheter into the heart to measure intracardiac pressures.
Heart failure affects more than 6 million Americans, and monitoring heart pressure is critical for managing the condition and preventing hospitalizations. Current methods require invasive procedures that carry risks and are typically performed only in clinical settings. Cardiosense’s technology uses external sensors and proprietary algorithms to estimate intracardiac pressures, potentially enabling more frequent monitoring in outpatient and even home settings.
The clearance is a milestone for Chicago’s growing health technology sector. Cardiosense is among a cluster of medical device and digital health startups that have emerged from the city’s hospital systems and research institutions in recent years. The company drew on talent from Northwestern University and the University of Chicago’s bioengineering programs.
Cardiosense said it plans a phased commercial launch, starting with cardiology practices in major metropolitan areas. The company has raised venture capital from healthcare-focused investors, though it has not disclosed total funding. The FDA clearance is expected to accelerate partnership discussions with hospital systems and value-based care organizations seeking tools to reduce heart failure readmissions.
Physicians who have followed the technology say the non-invasive approach, if validated in broader clinical use, could significantly improve patient quality of life and reduce the estimated $30 billion the U.S. spends annually on heart failure care.
Source: Crain’s Chicago Business | Business of Chicago
