FDA grants approval for Cardiosense's CardioTag Medical Device
Cardiosense's CardioTag Device Receives FDA Clearance for Revolutionary Heart Monitoring
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Cardiosense CardioTag device, marking a significant step towards the clinical adoption of this innovative, multimodal wearable heart monitor [1][3].
The CardioTag device is designed to simultaneously record electrocardiogram (ECG), photoplethysmogram (PPG), and seismocardiogram (SCG) signals, providing comprehensive, noninvasive cardiac monitoring [1][3]. Its primary applications and benefits include advanced cardiac function monitoring, heart failure management, enabling personalized, hemodynamic-guided care, lay user and home use, and serving as a noninvasive alternative to implantable sensors [1][2][3].
Beyond traditional rhythm analysis, CardioTag captures mechanical and hemodynamic data, offering a more complete view of heart function and blood flow [1]. In heart failure patients, it is being used in studies and clinical settings to help estimate cardiac pressures and volume status, showing accuracy comparable to implantable sensors but without invasive procedures or surgical risks [2][3].
The CardioTag device supports clinicians in guiding therapy both in hospitals and outpatient environments by providing actionable data on cardiac mechanics and pressures [2]. It is FDA-cleared for use by healthcare professionals and lay users, allowing patients to monitor their heart health at home, facilitating remote and self-directed cardiovascular disease management [3].
Cardiosense's mission is to advance cardiac care by providing a comprehensive noninvasive solution to assess cardiac function across care settings [4]. Omer Inan, PhD, Co-founder and Chief Scientific Officer at Cardiosense, stated that the FDA clearance is a significant milestone, marking a major step towards bringing precision hemodynamic insights into everyday patient care [5].
Upon regulatory approval for the PCWP Analysis Software, the algorithm will be paired with the CardioTag device for advanced heart failure management [1]. Cardiosense will begin exploring pilots with the CardioTag device paired with AI algorithms using the SCG, ECG, or PPG data from the device [6]. The effectiveness of Cardiosense's AI algorithm for pulmonary capillary wedge pressure (PCWP) has been demonstrated in a recent prospective, multicenter study published in the Journal of the American College of Cardiology: Heart Failure and presented as Late-Breaking Science at the American Heart Association's 2024 Scientific Sessions [2].
In summary, the Cardiosense CardioTag device offers comprehensive, noninvasive, multi-signal cardiac monitoring, improving diagnosis and management of cardiovascular diseases like heart failure, supporting personalized treatment decisions, and enabling home-based patient monitoring with AI-enhanced insights into heart mechanics and hemodynamics [1][2][3].
References: 1. Cardiosense 2. Cardiosense's AI Algorithm for PCWP Demonstrates Effectiveness in Heart Failure Management 3. FDA Clears Cardiosense's CardioTag Device for Noninvasive Multi-Signal Cardiac Monitoring 4. Cardiosense's Mission 5. FDA Clearance of Cardiosense's CardioTag Device Marks Major Step Towards Bringing Precision Hemodynamic Insights into Everyday Patient Care 6. Cardiosense to Explore Pilots with CardioTag Device Paired with AI Algorithms
