FDA Product Code MXD: Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection)

Under FDA product code MXD, implantable cardiac event recorders with arrhythmia detection are cleared for long-term cardiac monitoring.

These subcutaneous devices continuously monitor the heart's electrical activity for up to three years, automatically storing ECG data when arrhythmias are detected or when the patient activates the device. They are used to diagnose unexplained syncope, palpitations, and cryptogenic stroke.

MXD devices are Class II medical devices, regulated under 21 CFR 870.1025 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Medtronic, Inc., Boston Scientific Corporation and Biotronik, Inc..