A new coronary stent made of cobalt alloy and coated with a thin layer of protein may provide a welcome alternative to traditional bare-metal or drug-eluting stents. When placed in the body, the prohealing PROTEX coronary stent system from Nexeon MedSystems is recognized by the body as having the architecture of a normal artery. Hence, according to the start-up, the body begins to populate the stent quickly with regular functioning cells, rather than reacting to the stent as a foreign metal. Because the thin, low-profile stent platform is biomimetic, rapid healing should occur.
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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.
An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.
