The CareLine platform is a Class I software as a medical device (SaMD) intended for healthcare professionals to enable remote management of heart failure patients.
The CareLine HF-Platform is on the French Assurance Maladie’s reimbursement list for medical remote monitoring activities. Coverage is conditional to the activities being operated by a declared remote monitoring operator and to the patient following a therapeutic educational program.
Read carefully the healthcare professional instructions for use.
The CareLine platform is CE-marked as Class I under Directive 93/42/EEC (MDD). In accordance with Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR), this CE-marking is valid until 31 December 2028 as a result of Article 120(3b). A Class IIa certification procedure under MDR is ongoing.