myLUX Patient 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. The patient app is intended primarily for patient use.

Functional description

The patient procedure pack includes a myLUX patient app installed on an off-the-shelf mobile device used to program and interrogate the implanted LUX-Dx Insertable Cardiac Monitor (ICM). The included magnet is used to initiate communication between a LUX-Dx ICM and the myLUX patient app.