Health Canada is inviting feedback on two draft guidelines that explain the scientific information that device manufacturers should provide in support of their pre-market licence and amendment applications for Class III and IV in vitro diagnostics.
Health Canada is inviting feedback on two draft guidelines that explain the scientific information that device manufacturers should provide in support of their pre-market licence and amendment applications for Class III and IV in vitro diagnostics.
While one guideline explains the submission of this information in the global STED format (ie the Summary Technical Document), the other is meant for device manufacturers who are...
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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.
