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Cognitive Neurostim Devices: Promises, Unknowns Explored At FDA Workshop

Noninvasive electromagnetic neurostimulation devices designed to improve peoples’ memory or learning abilities currently show some promise, but also feature unknowns surrounding their mechanisms of actions and long term effects, said speakers at an FDA workshop on the devices.

Makers of noninvasive external electromagnetic neurostimulation devices intended to improve cognitive function often go unregulated now, but they may have to comply with FDA premarket device rules as marketing claims and technology evolves, said participants at a Nov. 20 FDA workshop.

Neurostimulation devices that rely on techniques including transcranial direction current stimulation (tDCS) or transcranial magnetic stimulation (TMS) to improve cognitive functioning could be regulated in the future if manufacturers make...

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• By Amanda Maxwell

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Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

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First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.