The push to bring patient opinions about what risk versus benefit they will accept into the formal regulatory process has advanced in recent days with the release of FDA draft guidance
and a consensus report
MDIC Catalog Outlines Patient Preference Methods
Sponsors who think patient preference could be a key factor to the approval of their device can look to the appendix section of the new MDIC report for study methods that can help support claims with information showing that patients may be willing to take on more risks to get their hands on the treatment.
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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.
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