Market Access Strategy for Medical Devices in Europe
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Med Tech-related health technology assessments from NIHR in July 2025
The National Institute for Health and Care Research (NIHR) funds valuable independent research for health and social care decision-makers in England. Reports from the Health Technology Assessment (HTA) Programme are published in the NIHR HTA Journal and inform the National Institute for Health and Care Excellence (NICE) guidance.
In July 2025, seven Med Tech-related assessments were published in the NIHR HTA Journal. Some examples of evaluations are provided below:
- Invasive urodynamic investigations in the management of women with refractory overactive bladder symptoms, based on the parallel-group, multicenter, superiority, open-label, randomized controlled trial and the cost-effectiveness analysis. It was concluded that participant-reported success in the urodynamics arm was not superior to the comprehensive clinical assessment-only arm at 15-month follow-up, and urodynamics is not cost-effective at a threshold of £20,000 per quality-adjusted life-year gained.
- Variation within and between digital pathology and light microscopy for the diagnosis of histopathology slides based on the blinded crossover comparison study. The researchers concluded that clinical management concordance levels between the two modalities exceed 98.3% in breast, gastrointestinal, skin, and renal specialties and pooled breast and large bowel cancer screening cases.
- Extracorporeal carbon dioxide removal for the treatment of acute hypoxemic respiratory failure, based on the multicenter, randomized, allocation-concealed, open-label, pragmatic clinical trial (REST RCT). It was concluded that there were no short- or long-term benefits, and the device was associated with higher cost and potentially significant complications. The researchers advised against using this technology in addition to standard care for treating patients with hypoxemic respiratory failure, outside of future clinical trials.
Other assessments published in July 2025 concerned nephrology and urology, gynecology, in-vitro diagnostics and pulmonary fields.
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