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PDP policy requirement for design verification data to be modified by FDA.
SIMPLIFIED PDP OUTLINE UNDER CONSIDERATION BY FDA as a complement to its comprehensive policy on product development protocols. The agency says it would like to retain the existing policy because it would be helpful to manufacturers less familiar with the premarket review process, such as new start-ups. However, it also wants to address complaints from some manufacturers that the comprehensive policy is too detailed and prescriptive, and to this end may develop a simplified format.
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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.
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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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The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
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The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.