CE-Mark

The CareLine platform is a CE-marked Class I medical device under Directive 93/42/EEC.
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The Alert Module of the CareLine IC platform is a Class IIa digital medical device that performs multiparametric analysis of patients’ physiological parameters using customizable algorithms. It generates alerts accordingly to support the remote management of chronic heart failure via the CareLine IC platform. It is intended for use by healthcare professionals managing chronic heart failure patients, under the supervision of a heart failure specialist.

⚠️ Remote management of heart failure is not intended to provide continuous patient monitoring or emergency care. Patients must be informed and appropriately educated.

📑 Please read the instructions for use carefully – for healthcare professionals only.

The CareLine IC platform is included on the French National Health Insurance reimbursement list for telemonitoring activities under Article L.162-52 of the French Social Security Code. Reimbursement is subject to the implementation of telemonitoring by a registered operator and to the patient’s participation in therapeutic education activities.