In-vitro diagnostic tests

Since January 2025, three MedTech-related mini-HTAs were initiated in the areas of men’s health, in-vitro diagnostics, and diagnostic imaging as a part of a framework for the managed introduction of innovations "New Methods" in Norway. Furthermore, 11 mini-HTAs were published in this period, including cardiovascular, e-health, gastrointestinal, men’s health, and spine areas.

In the first and second quarters of 2025, the Dutch Healthcare Institute (ZIN) published three coverage positions concerning the ENT, gastrointestinal, and in-vitro diagnostic fields. Two of the three decisions (Internal nasal valve correction for airway blockage and molecular diagnostics of the NTRK gene fusion in cancer patients) received favorable recommendations for coverage under basic health insurance.

In June 2025, the Skåne University Hospital (HTA South) is working on health technology assessments in several areas, including diagnostic imaging, e-health, in-vitro diagnostics, men’s health and neurology.

On June 18, 2025, a new version of the Nomenclature of Medical Biology Procedures (NABM 98) was released. Seven new codes were introduced.

On June 10, 2025, the Swiss Federal Office of Public Health published updates to the Healthcare Benefit Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The changes will take effect on July 1, 2025, and relate to colorectal cancer screening with the increase in the number of reimbursed colonoscopies, cancer treatment, men’s health, medical aids, and other medical services.

On June 5, 2025, the French National Authority for Health (HAS) published its favorable opinion on the coverage of AI-assisted digitalized urine cytology using VisioCyt Bladder, an in-vitro diagnostic medical device, under the renewed Repository of Innovative Procedures outside the Nomenclature of Biology and Anatomocytopathology (RIHN) 2.0.

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.

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.

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.

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 May 12, 2025, the updated version of the Finnish Laboratory Tests Nomenclature was published by the Finnish Institute for Health and Welfare (THL) to come into force on June 1, 2025. Twenty-one new codes were introduced.

On May 13, 2025, the Common Package of Benefits of the Spanish National Health System (NHS) was amended. The med tech-related updates mostly concerned in-vitro diagnostics, gastrointestinal, e-Health, cardiovascular, ENT, ophthalmology, oral health, and neurology fields.