by Tracy Neilssien
Neurointerventional device innovation has made great strides since the US Food and Drug Administration (FDA) approved tissue plasminogen activator (tPA)...
At this February's International Stroke Conference held in Los Angeles, the latest advances in cerebrovascular disease diagnosis, treatment, and prevention were highlighted, including cutting-edge endovascular therapies for use in acute ischemic stroke treatment and prevention, as well as new options for more deadly hemorrhagic stroke.
by Tracy Neilssien
Neurointerventional device innovation has made great strides since the US Food and Drug Administration (FDA) approved tissue plasminogen activator (tPA)...
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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.
The FDA's new Commissioner’s National Priority Voucher program aims to expedite drug approvals significantly. Device firms like XVIVO advocate for a similar initiative for devices, emphasizing the potential for faster reviews and improved patient access to lifesaving technologies.
Paul Campbell, chief regulatory officer at HealthAI, emphasizes existing regulations for AI in healthcare should not be overlooked as new regulations are developed.
The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.