French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 9 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May and April.
Recent published decisions that were made on the meeting of CNEDiMTS in April:
- RESORB X (range) and SONICPINS RX, resorbable plates and rivets for craniofacial osteosynthesis (5255) (application for registration, approved)
- PROCLAIM ELITE, recharge-free implantable neurostimulation medullar system (application for registration, approved)
- PRODIGY MRI, implantable medullary neurostimulation system (application for registration, approved)
List of new decisions that were made on the meeting of CNEDiMTS in May:
- XTEND FOOT H100, foot with energy restitution class III (application for registration, approved)
- CHALLENGER 1E95, foot with energy restitution class III (application for registration, approved)
- MYLIFE OMNIPOD, insulin management system (request for amendment, approved)
- RM PRESSFIT VITAMYS, hip prosthesis (element): cup (request for amendment, rejected)
- ATROSTIM, intrathoracic phrenic stimulator (request for amendment, approved)
- CLASSIC VISCO, memory foam pillow (administrative request for amendment of description of the product, approved)
List of devices that are still pending for decision after the meeting of CNEDiMTS in April:
- ULTIMASTER, coronary endoprosthesis with sirolimus (renewal of condition for registration)
- MAGNEZIX CS, bioresorbable screw for osteosynthesis (application for registration)
- ESSURE, Intrafallopian implant - device for hysteroscopic tubal sterilization (5260 and DM_EVAL-143) (renewal of registration)
- PENUMBRA 3D, thrombus reuptake system (retriever) (5251), PENUMBRA PACKAGE SYSTEM, Thrombus aspiration kit (ACE60 and ACE68) (5235) (application for registration)
- MELODY with percutaneous implant system ASSEMBLY, percutaneous ultrasonic valve with implantation system (5264) (renewal of registration)
- MELODY with percutaneous implant system ASSEMBLE II, Percutaneous pulmonary valve with implantation system (5223) (application for registration)
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