OBJECTIVES: The Medical Devices Committee (MDC) of the Maggiore Policlinico Hospital in Milan, Italy, approved the use of a minimally invasive insertable cardiac monitor (ICM). ICMs are leadless subcutaneous devices that continuously monitor the heart rhythm and record events, allowing for the diagnosis of infrequent rhythm abnormalities that can be the cause of palpitations, syncope and stroke. Given the limited available literature and foreseen increase in expenditure, the MDC established an outcome monitoring process in order to test the effectiveness of the device in real practice in detecting abnormal heart rhythms and therefore diagnose and implement a timely appropriate treatment. METHODS: According to the literature, available guidelines and clinical opinion, four groups of patients would potentially benefit from the ICM insertion: patients with syncope of unknown etiology, myocardial infarction (e.g., arrhythmia risk stratification after the event), relapsing arrhythmia after transcatheter ablation of atrial fibrillation (AF) and cryptogenic stroke. A standardized data collection form was developed for requesting the device to the hospital pharmacy, including patient’s characteristics and clinical condition for use.  A follow up report describing clinical outcomes (e.g. detected arrhythmias, time to event, diagnostic formulation) needs to be provided every 6 months.  RESULTS: From 7/2014 to 5/2015, the ICM was implanted in 14 patients. The average patients’ age at the time of insertion was 54,8 years (range: 27-84 years). 78,6% of patients(11) showed syncope of unknown etiology, 14,2%(2) suffered a cryptogenic stroke, while 1 patient(7,1%) received transcatheter ablation of AF with possible anticoagulant/antiarrhythmic therapy suspension.  A final diagnosis was reached for 5(36%) patients; in particular, for 2 a sustained arrhytmia was detected within 15 days since the implant. CONCLUSIONS: The inclusion in clinical practice of a new technology has increased the expenditure for medical devices. However, the forthcoming availability of clinical outcomes will document whether the diagnosis process has been improved.