Market Access Strategy for Medical Devices in Europe
Strategic recommendations on the topic of market access pathways for medical devices and IVD tests
White Paper: Evidence requirements for medical devices in the “New methods” framework in Norway
Get insights from MTRC White Papers to explore the evidence requirements related to the 'New Methods' framework from the 5 recent med tech assessments in Norway.
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Favorable coverage decision for MR-guided focused ultrasound for essential tremor in Norway
Norway has a national framework for the introduction of new health technologies within the specialist health service, known as the "New Methods" framework. This framework requires that all innovations undergo a national or hospital-based health technology assessment (HTA) prior to funding approval.
The magnetic resonance-guided high-intensity focused ultrasound (MRgFUS, ExAblate Neuro by Insightec) for the treatment of essential tremor has been under evaluation within the "New Methods" framework since 2023. In January 2025, the HTA was completed by the Norwegian Medical Products Agency (NOMA), and the case was prepared for the Decision phase in May 2025.
On October 20, 2025, the Decision Forum for “New Methods” reached the following conclusion:
- MRgFUS is being introduced for the treatment of patients with treatment-resistant, moderate to severe essential tremor who cannot or do not wish to undergo Deep Brain Stimulation (DBS);
- The treatment will be established at a single site. The medical directors will assess the advantages and disadvantages of Oslo University Hospital and St. Olavs Hospital HF, and the matter will be presented at the Executive Director meeting no later than December 2025;
- The method may be implemented once the necessary agreements between the relevant supplier and the regional health authorities have been concluded. The estimated start date is mid-February 2026;
- It is assumed that the price is equal to or lower than the price on which this decision is based, with the adjustment specified in the agreement.
See the full details here.
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