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European Market Size Analysis for Medical Devices

Market size and comparative landscape using reliable hospital statistics

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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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Reimbursement summary for angioplasty of arteries of lower extremities

This post presents an extract from our reimbursement analysis for angioplasty of arteries lower extremities using plain and drug-coated balloons (DCBs) for peripheral artery disease in England, France and Germany. Plain balloon angioplasty is reimbursement via DRG solely and DCBs are reimbursement via combination of DRG and add-on reimbursement.
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Favorable coverage decision for intermittent negative pressure therapy of the extremities in Norway

Norway has a national framework for introducing 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.

Intermittent negative pressure therapy (FlowOx), which is a non-invasive treatment for conditions related to reduced blood circulation in the extremities, has been evaluated within the "New Methods" framework. 

FlowOx is indicated for the treatment of peripheral arterial disease, intermittent claudication and rest pain, diabetic and non-diabetic arterial foot and leg ulcers, as well as pain, spasticity, or discomfort associated with immobility. The treatment can be performed at home by the patient themselves.

Two mini-HTAs within the "New Methods" framework have previously been carried out at Oslo University Hospital (in 2017 and a reassessment in 2021). The overall conclusion was that FlowOx increased blood flow in the legs of patients with impaired arterial circulation and improved walking distance and wound healing in patients with peripheral circulatory insufficiency.

In December 2025, the Ordering Forum for New Methods commissioned the Hospital Procurement Authority (Sykehusinnkjøp HF) to prepare a price note.

The price note completed in February 2026 states that there was no national or regional procurement structure for the method at that time, and that existing agreements had been established locally. It also concludes that a regional or national approach would be advisable to ensure efficient procurement and equitable access. Detailed pricing and budget impact information are not publicly disclosed in the price note. 

On March 16, 2026, the Decision Forum for “New Methods” reached the following conclusion:

  • Intermittent negative pressure therapy (FlowOx) is introduced as a non-invasive treatment for conditions related to reduced blood circulation in the extremities;
  • This is conditional on whether the price is equal to or lower than the price that is the basis for this decision. New procurements should be postponed until formal agreements with the supplier are in place.

See the full details in Norwegian here.

This news is just one of about 300 market access news collected by our team in the premium subscription service Market Access Monitor every week from more than 80 organizations. Access our paid service to stay on top of all developments, specifically for your products in Europe (reimbursement news) and globally (HTA news). Access is organized as an online Database and email alert formats. Contact us to get a free, three-month, no-obligation trial.