The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in May 2019.
Eleven (11) decisions were released regarding orthopedic devices:
- VANDA_D, long-lasting series therapeutic shoes for adults (application for registration, approved)
- VENEZIA_D, long-lasting series therapeutic shoes for adults (application for registration, approved)
- OCTAVIO_D, long-lasting series therapeutic shoes for adults (application for registration, approved)
- VELINA_D, long-lasting series therapeutic shoes for adults (application for registration, approved)
- ORFEO_D, long-lasting series therapeutic shoes for adults (application for registration, approved)
- VALENTINA_D, long-lasting series therapeutic shoes for adults (application for registration, approved)
- FIXA DUPLEX (to be cemented), double mobility cup with cemented cup and conventional polyethylene or highly cross-linked polyethylene insert (application for registration, approved)
- FIXA DUPLEX (without cement), double mobility cup with cemented cup and conventional polyethylene or highly cross-linked polyethylene insert (application for registration, approved)
- ONIRIS PRO, mandibular advancement orthosis (OAM) (application for registration, approved)
- ARGUS II, retinal prosthesis system (application for registration, approved)
- MENISCAL CINCH II, meniscal anchor (application for registration, approved)
Two (2) decisions were released for cardiovascular devices:
- AVANTGARDE CHRONO CARBOSTENT, coronary endoprosthesis (stent) coated with carbon (product without pharmacological action) (renewal of registration, approved)
- ELUNIR, coronary endoprosthesis (stent) coated with ridaforolimus (pharmacologically active product) (administrative amendment - changes in the wording, thus packaging and labelling)
Eleven (11) decisions were released for other devices:
- COLLECTEUR EXPRESS, Drain collecting system for high flow liquid stool (change of indications and renewal of registration, approved)
- SOLOIST, radiofrequency needle electrodes (application for registration, approved)
- LEVEEN, radiofrequency needle electrodes (application for registration, approved)
- INVACARE COLIBRI OUTDOOR 4 WHEELS, modular electric scooter (application for registration, approved)
- INTERSTIM I, neuromodulator of sacral roots (cancelled)
- FREESTYLE OPTIUM NEO, apparatus for automated automatic reading of blood glucose and ketones (renewal of registration, approved)
- DIGISONIC SP ABI, brainstem implant (renewal of registration, approved)
- Mi1200 SYNCHRONY ABI and Mi1200 SYNCHRONY PIN ABI, brainstem implant (renewal of registration, approved)
- CATIONORM in multidose vial, emulsion for ophthalmic use (renewal of registration, approved)
- CATIONORM in single doses, emulsion for ophthalmic use (renewal of registration, approved)
- DIGI SP - SPK DIGI - DIGISONIC BTE – ZEBRA, sound processor (cancelled)
See the list of decisions in French here.
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