European News In Brief
EU human tissue regulation: DG Enterprise will likely release an independent human tissue product draft directive in June 2003, arousing European industry concern over the possibility of two separate circulating directives. Eucomed's public policy focus group has responded favorably to DG Sanco's proposed directive setting out quality requirements for processing human tissues and cells, set for approval before 2004. Enterprise's initiative also was well received by industry, since manufacturers are expected to be "treated on the same basis as tissue banks." The Sanco directive, founded on Article 152 under the Amsterdam Treaty, is an EU Health Policy initiative. The DG Enterprise proposal, meanwhile, aims to create an EU-wide regulatory framework for marketing tissue products...
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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.
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Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?
Many of the hundred-plus commenters to the FDA's draft guidance on AI in medical product regulation said the document was a good start but needed additional clarity and more concrete examples. Stakeholders recommended the inclusion of case studies, metrics, and clearer guidelines to enhance the utility of the guidance, which is seen as a vital step for AI integration in healthcare.
A change of government, hospital reform and a drive towards healthcare digitization are keeping German medtech manufacturers on their toes. Making the MDR more user-friendly and winning support for a medtech strategy are arguably bigger priorities. US export tariffs have also pushed their way onto the agenda. BVMed chief executive Marc-Pierre Möll puts it all into context.