News and blog posts

04

Sep 2020

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. Read more

03

Sep 2020

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). Read more

02

Sep 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) issued an updated report on the PET/PET-CT evidence for need-based planning in Austria. Read more

01

Sep 2020

In July 2020, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (for artificial iris insertion for acquired aniridia and for congenital aniridia), and two Medtech innovation briefings (for Prontosan for acute and chronic wounds, and CFHealthHub for managing cystic fibrosis during the COVID-19 pandemic). Read more

31

Aug 2020

The procedure for applying the ‘subsidy scheme for promising care’ is opened again. The period for applying has started on July 22 and will last till September 22, 2020. Read more

28

Aug 2020

In July 2020, the network of European HTA agencies, EUnetHTA, announced a final project plan of the project OTCA25 “Stereotactic Body Radiation Therapy (SBRT) for lung, prostate, and liver cancer.” Read more

27

Aug 2020

In August 2020, mHealthBelgium announced two more health application accomplished M2 validation - Well@Home and AirView. After achieving M2 level, developers will get access to more options, like risk assessment framework, test centers, a lot of useful information. Read more

26

Aug 2020

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. Read more

25

Aug 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are leadless pacemaker for right ventricle pacing and extracorporeal cytokine hemadsorption therapy in patients with sepsis or SIRS. Read more

24

Aug 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. Read more

21

Aug 2020

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. Read more

20

Aug 2020

The Institute for Quality and Efficiency in Health Care (IQWiG) investigated the extent to which evidence is available for the benefit and harm of non-invasive computed tomography angiography (CTA) and stress diagnostics using magnetic resonance imaging (MRI) in people with suspected coronary heart disease (CAD) using evidence mapping. Read more