U.S. device industry reps expect Japanese "R-zone" price cuts to more closely approximate market conditions than foreign average pricing (FAP) revisions
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Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.
In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.
Notified bodies are calling for their key role, as the technical, regulatory and clinical ‘extended arm’ of regulatory authorities, to remain central to the EU medtech conformity assessment process.
Thermo Fisher said the year-over-year impact of tariffs and related effects represented a 5% headwind to adjusted operating income and reduced reported margins by 140 basis points in the second quarter.
The US FDA has announced its user fees for fiscal 2026, which are based on a figure of $455,000 for a PMA.
