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 December 2018. The decisions were brought for ten (10) medical devices.
One (1) decision was released regarding prostheses:
- GLASSBONE INJECTABLE PUTTY, injectable synthetic bone substitute (application for registration, rejected because the available data do not establish the interest for this product)
One (1) decision was released regarding cardiovascular devices:
- CRT 8000, triple chamber pacemaker (canceled)
Eight (8) decisions were released regarding other devices:
- IALUSET PLUS, cream, and compresses (Hearing under article R165-5 of the Social Security Code)
- SIR-Spheres, (application for amendment of the registration conditions, approved)
- ALBER E-PILOT, traction device with electric drive for a manual wheelchair user (application for registration, rejected because the available data do not establish the interest for this product)
- IN.PACT ADMIRAL, paclitaxel-eluting balloon (application for amendment of the registration conditions, approved)
- SENTRY 1200 ST, automatic motorized air mattress with constant pressure and / or dynamic pressure of more than 15 cm of air thickness (application for renewal of registration, approved)
- SYNCHROMED II (reference 8709SC), programmable implantable pump with the variable flow (canceled)
- SPECTRA WaveWriter, implantable and rechargeable system of medullary stimulation (application for registration, approved)
- EDEN, lubricated male condoms (application for registration, approved)
See the full list of decisions in French here.
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