Roche Diagnostic microarrays will be sold as research-use only tests until the firm is able to seek in vitro diagnostic status, Robert Gregg, PhD, director of regulatory submissions, explained during the American Association of Clinical Chemistry annual meeting in Los Angeles July 26
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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.
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.
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.
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.
