Proposed infant apnea monitor standard based on bench testing is released by FDA.
INFANT APNEA MONITOR STANDARD BASED ON BENCH TESTING rather than clinical trials is proposed by FDA in a Feb. 21 Federal Register notice. The revised version of the standard was expected to include clinical testing requirements, but FDA says that performance of apnea monitors currently on the market can be demonstrated without clinical trials. Comments on the proposal are due by May 22.
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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.
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