The Ear, Nose and Throat Devices Panel will convene for two days, April 30 and May 1, first to recommend risk-classification categories for five types of hearing devices and, on the second day, consider the potential of moving clinical requirements for cochlear implant modifications for kids to the postmarket phase.
The prospects of shifting clinical data requirements from premarket to postmarket to support cochlear implant modifications for pediatric patients will discussed at an upcoming FDA Ear, Nose and Throat Devices Panel meeting.
The panel will meet April 30 and May 1 first to recommend risk-classification categories for five types of hearing devices...
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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.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
MedTech Europe is ready to become involved and shape Europe’s Life Sciences Strategy and help drive regulatory simplification from the top to make the EU “the world’s most attractive place for life sciences by 2030.”
The UK government’s blueprint to deliver an NHS "fit for the future" was released on July 3.
