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News and blog posts

21
Aug 2023

Publication Digest: Development and validation of Medical Device Key Evidence Tool ('MeDKET'): An evidence-based framework to explain success in selected European and US companies

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Manetti et al. developed a novel framework for assessing readiness in successful Medical Device (MD) development and deployment. Through a four-stage process, the authors developed and validated checklists for both small (21 items) and large (15 items) enterprises. The study identified three key drivers of MD success: R&D assessment strategy, device-outcome measures, and company profiling. Additional retrospective validation with 40 case studies on MDs highlighted the crucial role of early Health Technology Assessment in industry success, varying by enterprise size.
18
Aug 2023

Ongoing HTAs by OSTEBA in Spain in August 2023

In August 2023, the Basque Office for Health Technology Assessment (OSTEBA) is working on several HTAs, including the evaluations in the cardiovascular, diagnostic imaging, e-health, ENT, ICU/OR, nephrology and urology, IVD, neurovascular, obstetrics and gynecology, surgical procedures, and some other fields.
16
Aug 2023

Med Tech-related HTAs published by Irish HIQA in the second quarter of 2023

Health Information and Quality Authority (HIQA) is an independent statutory authority that develops national health technology assessments to support decision-making in Ireland. In the second quarter of 2023, HIQA published one new Med Tech-related assessment concerning slot-scanning biplanar digital X-ray imaging systems for orthopedic conditions.
15
Aug 2023

First technology for 2024/25 MedTech Funding Mandate selected in England

In August 2023, NHS England announced the first technology (AposHealth) that will be supported by the MedTech Funding Mandate (MTFM) in 2023/24. MTFM supports NICE-approved, clinically effective, and cost-saving medical devices, diagnostics, and digital technologies, making it mandatory for commissioners and providers to implement them.
14
Aug 2023

New HTAs initiated in Poland

In early August 2023, the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT) announced the start of the evaluation of several technologies in men’s health, neuromodulation and in-vitro diagnostics fields.
11
Aug 2023

Med Tech-related HTAs in Wales published in July 2023

In July 2023, Health Technology Wales completed one full appraisal on wearable cardioverter defibrillators with the publication of Evidence Appraisal Report (EAR) and Guidance. Furthermore, in July 2023, Health Technology Wales decided to proceed with a full appraisal of radiofrequency renal denervation in the treatment of resistant hypertension based on the published Topic Exploration Report.
08
Aug 2023

2025 DRG applications now accepted in Denmark

On July 31, 2023, the Danish Health Data Authority opened the application period for changes in the 2025 DRG logic, including the creation of new DRG codes and changes in the grouping logic for existing DRGs. The deadline for the submission of the applications is November 10, 2023.
07
Aug 2023

First positive opinion for coverage in “Early coverage of digital medical devices” (PECAN) framework

On July 31, 2023, the National Committee for the evaluation of medical devices and health technologies (CNEDiMTS) at the French National Authority for Health (HAS) published the first positive opinion on the “Early coverage of digital medical devices” (PECAN) framework. The positive opinion is provided to CUREETY TECHCARE medical telemonitoring solution, which is used for medical telemonitoring of adult cancer patients under systemic treatment and/or treated with radiotherapy.
04
Aug 2023

MedTech-related health technology assessments from NIHR in July 2023

In July 2023, the National Institute for Health and Care Research (NIHR) in England released one MedTech-related report in its Health Technology Assessment (HTA) Journal concerning MRI-based technologies for diagnosing non-alcoholic fatty liver disease. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and informs National Institute for Health and Care Excellence (NICE) guidance.