FDA Centralization Plan Under Review; HHS Aiming For “One Clear Message”
Consolidation of HHS public affairs and legislative activities across the department will blunt the political impact of the incoming FDA commissioner, potentially allowing the position to focus on science policy and product review issues
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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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Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.
With a projected FDA submission within the next two to three years, Harbinger is prioritizing cancers based on lethality, prevalence, and unmet diagnostic need. Pancreatic and biliary cancers – often diagnosed at late stages and lacking established screening programs – will be among the initial targets.
Dexcom’s relatively strong position amid tariff-related uncertainty is rooted in its long-standing investments in domestic manufacturing, but raw material inflation is driving cost concerns even in the face of operational efficiencies.