FDA will immediately begin recognizing the third edition of the International Electrotechnical Commission's (IEC) family of standards for medical electrical equipment safety and performance. The third edition of IEC 60601 represents a major overhaul of the existing standard, namely by requiring medical electrical equipment manufacturers to have formal risk-management processes in place. The third edition was published in 2005, but FDA reviewers needed time to adjust to the new risk-management piece, FDA's standards management director Carol Herman explained at a March 9 session of the AAMI/FDA International Conference on Medical Device Standards and Regulation in Reston, Va. Firms will have three years to switch over to the new standard. A Federal Register notice on the topic is expected soon, Herman said
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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.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
