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 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.