FDA Seeks Feedback On Brain-Computer Interface Devices For Amputees
The agency has scheduled a November workshop on brain-computer interface devices to discuss scientific, clinical and regulatory considerations for firms designing neuroprostheses that work with the central nervous system to help restore motor capabilities in paralyzed and amputee patients. The meeting could inform development of a draft guidance.
FDA will host a public workshop Nov. 21 to collect feedback on “brain-computer interface devices” for patients with paralysis and amputation. The workshop may facilitate development of a draft guidance on premarket submissions for emerging BCI technologies, CDRH said
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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
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In revising the foundations of EU product legislation, the European Commission aims to increase harmonization, cut regulatory burdens and promote digital tools to boost compliance and safety.
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