Regulatory

The following Cardiosense devices are authorized for sale and distribution in the US by the FDA as Class II medical devices:

CardioTag™ Device

A wearable sensor that captures a patient’s seismocardiographic (SCG), electrocardiographic (ECG), and photoplethysmographic (PPG) signals.

CardioTag™ Device — Instructions for Use

PCWP Analysis Software

A standalone AI-powered software-as-a-medical device that noninvasively estimates pulmonary capillary wedge pressure (PCWP) from SCG, ECG, and PPG signals.

PCWP Analysis Software — Instructions for Use

For additional regulatory information, please see the links below or use the Contact Support button to reach our team.

Cardiosense operates under a Quality Management System compliant to 21 CFR 820 and ISO 13485.