In May 2025, Health Technology Wales (HTW) accomplished one full appraisal on advanced electrosurgical bipolar vessel sealing systems during hysterectomy. One Med Tech-related Topic Exploration Report was published on AMBLor for identifying low-risk non-ulcerated early-stage cutaneous melanomas.

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, Basu et al. investigated whether health technology assessment (HTA) agencies systematically consider unique characteristics of medical devices in their guidelines and reports. Specifically, the study examined factors such as learning curve, incremental innovation, dynamic pricing, and organizational impact through a review of documents from 14 HTA agencies, five HTA networks, and the published literature. The authors identified inconsistent inclusion of device-specific attributes, with most agencies lacking comprehensive methodological guidance, underscoring the need for standardized frameworks in future HTA processes.

In May 2025, the HTA body of Tuscany Regional Healthcare published seven rapid HTA reports (six new assessments and one reassessment) of medical devices in the cardiovascular, e-health, intensive care and operating room, neuromodulation, ophthalmology, and orthopedics fields.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Sustainability Publications Digest. In a recent publication, Qin et al. assessed the economic and environmental impact of single-use instruments (SUIs) versus reusable instruments (RUIs) in cataract surgery across six centers in Europe and the United States. The analysis found that annual costs for SUIs were lower or similar to those of RUIs in four out of six centers, with the greatest cost-effectiveness observed in facilities where sterilization costs were highest. Over a five-year period, however, the carbon footprint of SUIs was substantially greater: 5,478.2 kg CO₂ eq without recycling and 4,639.9 kg CO₂ eq with recycling, compared to just 20.6 kg CO₂ eq for RUIs. These findings suggest that while SUIs may offer financial advantages in some hospital settings, they pose a significant environmental impact.

On May 23, 2025, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system and associated tariffs to be implemented no later than September 1, 2025. A total of 55 new codes were added in the biochemistry, microbiology, clinical pharmacology, and immunology fields.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Health Economic Publications Digest. In a recent publication, Reason et al. introduced how generative artificial intelligence (GenAI), particularly large language models (LLMs) like ChatGPT, can support health economics and outcomes research (HEOR). The authors highlight that LLMs can streamline a range of HEOR activities, including literature summary, data extraction, report drafting, and statistical code generation. However, they also point out key limitations, such as the risk of hallucinated outputs, security vulnerabilities, reproducibility issues, and potential bias. Implementing LLMs in HEOR necessitates robust security measures to ensure compliance with the European Union’s General Data Protection Regulation (GDPR) and the United States’ Health Insurance Portability and Accountability Act (HIPAA) when handling sensitive data.

On May 26, 2025, the Innovation Committee at the Federal Joint Committee (G-BA) announced that 49 applications for innovation funding of healthcare research projects were accepted.

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its EU HTA Publications Digest. In a recent publication, Gupte et al. conducted a review of accelerated approval pathways for medical devices in the United States and the European Union. The authors found that while the US Breakthrough Devices Program granted marketing authorization to just 12.3% of 1,041 designated devices between 2015 and 2024, approval was achieved substantially faster than through standard routes. In the EU, where no specific accelerated pathway exists, newly introduced Medical Device and Health Technology Assessment Regulations aim to harmonize approvals, with joint clinical assessments set to begin in 2026. The authors highlight that aligning regulatory, funding, and coverage policies is essential for device accessibility, and call for global convergence of standards and post-market surveillance to balance innovation with patient safety.

In May 2025, the National Institute for Health and Care Research (NIHR) in England released five Med Tech-related assessments in its HTA Journal, which concerned the evaluation of high-flow nasal cannula therapy in pediatric critical care, assessment of IVD tests for guidance of antibiotic treatment, and the results of the research on clinical and cost-effectiveness of first-trimester ultrasound screening for fetal anomalies. 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 NICE guidance.

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, Dietrich examined the current and potential roles of artificial intelligence in pricing, reimbursement, and market access (PRMA) processes, focusing on Germany and broader EU implications. The study highlighted that AI could help forecast HTA agency decisions and streamline tasks like literature reviews and submissions. However, its use in HTA remains limited due to strict transparency demands, the need for explainability and human oversight, and the sensitive nature of PRMA documentation, especially in critical negotiations. The author concludes that while AI has transformative potential, its adoption should be gradual and supported by close collaboration among stakeholders. Broader use will depend on robust evidence of performance and cost-effectiveness compared to traditional methods.

On May 27, 2025, a new version of the Nomenclature of Medical Biology Procedures (NABM 97) was released. Changes concerned the introduction of a new code and modifications to the descriptions and wording of several existing codes.

On June 2, 2025, the submission period for Joint Scientific Consultations (JSCs) requests under the EU Health Technology Assessment Regulation (HTAR) framework opened. JSCs offer health technology developers the opportunity to seek scientific advice on the information and evidence required for a potential future Joint Clinical Assessment (JCA). Requests related to both medical devices and medicines can be submitted until June 30, 2025.