As of 31 January 2013, the familiar and well-used horizontal EU labelling standard for medical devices, EN 980 – which applies to medical devices and in vitro diagnostics across the board – is being replaced with a globally recognised standard: EN ISO 15223-1.
As of 31 January 2013, the familiar and well-used horizontal EU labelling standard for medical devices, EN 980 – which applies to medical devices and in vitro diagnostics across the board – is being replaced with a globally recognised standard: EN ISO 15223-1.
EN ISO 15223-1 – Medical devices - Symbols to be used with medical device labels, labelling and information to be...
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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.
