Edwards Lifesciences’ Sapien transcatheter aortic valve met widespread expectations last week by gaining support for FDA approval from an agency advisory panel, but the experts urged FDA and Edwards to proceed cautiously.
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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.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals and laid off librarians have not been reinstated.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
While MedTech Europe sharpens its focus on what the EU most urgently needs to advance the medtech market in four targeted measures, the European Commission has also unveiled four priorities for 2025.
