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AdvaMed Seeks More Safeguards For Distributing Off-Label Journal Articles
The device industry wants more protection than that supplied in draft FDA guidance on appropriate dissemination of journal articles for studies of non-approved product uses, while some members of Congress believe distribution of off-label study information should be banned outright
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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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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
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At AdvaMed’s MedTech Conference in San Diego, speakers brainstorm ways to bring devices to treat children to market more quickly through creative collaboration, better use of real-world data, and taking advantage of ‘low-hanging fruit’ like expanded size ranges.
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Though the advance of remote medical device technology allows for better at-home care, it comes with challenges and risks, says AdvaMed, which has published a safety bulletin guiding stakeholders on the operation of remote devices.