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News and blog posts

04
Sep 2020

Introduction of a separate group for software in the regulatory nomenclature of medical devices in Russia

The Ministry of Health has adjusted the regulatory nomenclature of medical devices, separating software, which is a medical device, into a separate group. The classification of software is given depending on the potential risk of its use. A potential risk class is assigned to software regardless of the potential risk class of the medical device in combination with which it is used. The order does not apply to medical products previously submitted for state registration.
03
Sep 2020

Autologous chondrocyte implantation in the knee assessed by IQWiG in Germany

On behalf of the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG) investigated to what extent adults with symptomatic knee cartilage defect (but without advanced arthrosis) could benefit from autologous chondrocyte implantation (ACI) of different types: periosteal-covered (ACI-P), collagen-covered (ACI-C) or matrix-associated (M-ACI).
26
Aug 2020

Brief HTAs of eleven medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 12735 of August 13, 2020, Tuscany Regional Healthcare has published assessments of eleven medical devices of various therapeutic areas, including peripheral nerve stimulator, catheter for renal denervation, EKOS technology and others.
24
Aug 2020

Decisions about add-on reimbursement for medical devices in France in July 2020

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 July 2020. Decisions concern drug-eluting coronary stents, TAVI, orthopedic appliances, wound dressing, stoma obturator, toric intraocular lens.
21
Aug 2020

Newborn screening for inherited metabolic disorders assessed by Spanish Avalia-T

In the middle of 2020, the Galician Scientific and Technical Advice Unit (Unidad de Asesoramiento Científico-técnico, Avalia-T) released a health technology assessment on clinical Effectiveness of newborn screening for inborn errors of metabolism by MS/MS that aimed to update the data collected in the pilot study. It is recommended to define health indicators, optimum and acceptable levels of some process indicators.