FDA Approps Amendment Targets Chief Counsel Troy
FDA Chief Counsel Daniel Troy's intervention in civil suits on behalf of device maker Pacesetter and several drug firms has drawn a rebuke from House legislators in the form of funding cuts
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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.
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The FDA staff cuts will probably mean longer device review times at least in the short term, speakers said at a recent webinar. But innovations like AI and third-party review could offer some hope, even as tariffs create a new set of problems.
Product reviews for drugs, biologics, devices, tobacco and foods could be consolidated into one office at the FDA, as part of a restructuring plan circulating that was obtained by Pink Sheet.
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?