LUX-Dx Clinic Assistant Kit with mobile device - Implantable cardiac device management application software

Intended purpose

Software app that is installed on non-medical off-the-shelf mobile devices and function by collecting and transmitting event, patient, and device data. It is intended for use during in-clinic follow-up sessions with patients who have an ICM device. It can also be used at insertion to view current device status and view real-time S-ECG.

Functional description

The clinician procedure pack includes a LUX-Dx Clinic Assistant app used by the clinician to program and interrogate an implanted LUX-Dx Insertable Cardiac Monitor (ICM). The included magnet is used to initiate communication between a LUX-Dx ICM and the LUX-Dx Clinic Assistant app