Cardiosense

Cardiosense introduces a noninvasive, point-of-care pulmonary artery pressure monitor for heart failure patients.

The FDA has authorized over 1,400 AI-enabled medical devices, marking rapid innovation in clinical technology.

How regulatory science and a sustained working relationship with the FDA turned two decades of engineering into a first-in-class device, and why its Predetermined Change Control Plan may outlast the…

Peer-reviewed research on wearable hemodynamic monitoring, noninvasive PCWP estimation, and seismocardiography from the Cardiosense team and collaborators.

Cardiosense engineers, scientists, and clinicians develop cardiac monitoring solutions, with details on their mission and team.

CardioTag is the world's first noninvasive device delivering PCWP at point-of-care, enabling clinicians to precisely manage Heart Failure patients. FDA-cleared Class II.

CardioTag and PCWP Analysis Software are FDA-cleared Class II medical devices. 510(k) clearance, quality management system, and compliance information.

Cardiosense secures FDA De Novo clearance for its AI-powered software analyzing pulmonary capillary wedge pressure (PCWP) noninvasively. The solution uses a chest-worn sensor to enable remote monitoring without invasive procedures. The approval marks a step toward broader adoption of digital diagnostics in cardiovascular care.

May 2026Medical Product OutsourcingNews article

Cardiosense secures FDA clearance for its AI-driven software, which uses wearable sensors to estimate cardiac pressure noninvasively. The tool aims to improve remote monitoring for patients with heart failure. The technology eliminates the need for invasive procedures, potentially enhancing patient comfort and care efficiency.

May 2026medicaleconomics.comNews article

The FDA grants **Cardiosense** De Novo clearance for its **PCWP Analysis Software**, enabling estimation of filling pressures in adults with **heart failure with reduced ejection fraction (HFrEF)**. The software supports clinical decision-making by providing non-invasive cardiac pressure assessments. The approval follows the FDA’s De Novo pathway for low-to-moderate-risk medical devices.

May 2026hcplive.comNews article

Cardiosense secures $15.1 million in Series A funding to advance its AI-driven cardiovascular disease detection platform. The Chicago-based company combines artificial intelligence with multi-sensor devices for early risk identification. This funding supports further development of its digital health solutions targeting heart health monitoring.

Dec 2022The SaaS NewsNews article