The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.
US FDA drafts guidance on computer-assisted detection devices
The US Food and Drug Administration has issued two related draft guidance documents on computer-assisted detection (CADe) devices applied to radiology images and radiology device data1.
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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.
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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.