The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of 12 medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in December.
Four decisions were released for respiratory prostheses for total laryngectomy with or without phonatory implants:
- PROVOX HME, (application for registration, approved)
- BLOM-SINGER, (application for registration, approved)
- PROVOX HME , (renewal of registration, approved)
- PROVOX XtraHME / MICRON / TRACHPHONE, (application for registration, approved)
Three decisions were issued for cardiovascular devices:
- JARVIK 2000, ventricular assist device (administrative amendment)
- CoreValve Evolut PRO, transcutaneous bioprosthetic aortic heart valve (application for registration, approved)
- GLIDELIGHT, laser sheath for extraction of stimulation probes and cardiac defibrillation (application for registration, approved)
Two decisions were published about mandibular advancement devices:
- TALI, (renewal of registration, approved)
- TWICARE, (application for registration, rejected due to insufficient expected benefit (AS))
Three decisions consider other devices:
- ACRYSOF IQ TORIC, intraocular monofocal toric lens (application for registration, approved)
- HOMEFILL II, home oxygen system (renewal of registration, approved)
- PHYSIOTULLE, wound dressing (renewal of registration, approved)
See list of decisions in French here
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