EU

The European Society for Brain Stimulation opposes EU reclassification of TMS and tDCS, claiming a flawed safety assessment

by

Man­i­festo: Oppo­si­tion to EU Reclas­si­fi­ca­tion of TMS and tDCS equip­ment to Class III devices based on flawed evi­dence (Euro­pean Soci­ety for Brain Stimulation):

It has recent­ly come to our atten­tion that the EU has reclas­si­fied the NIBS equip­ments includ­ing rTMS and tDCS, as Class III devices, the cat­e­go­ry of high­est risk, sim­i­lar to inva­sive treat­ments, such as deep-brain stim­u­la­tion implants. This reclas­si­fi­ca­tion has a major impact on our field, not only for man­u­fac­tur­ers, but also for researchers, clin­i­cians and patients and we judge this reclas­si­fi­ca­tion a mis­take. First, the evi­den­tial basis for this change is a flawed assess­ment of the safe­ty lit­er­a­ture. Sec­ond, the con­sul­ta­tion process has occurred with­out input from spe­cial­ists or stake­hold­ers pro­fes­sion­al­ly active in the field of NIBS. Nei­ther the ESBS nor Nation­al Soci­eties of Brain Stim­u­la­tion nor indi­vid­ual experts with­in the Euro­pean NIBS com­mu­ni­ty were con­sult­ed on this change. [Read more…] about The Euro­pean Soci­ety for Brain Stim­u­la­tion oppos­es EU reclas­si­fi­ca­tion of TMS and tDCS, claim­ing a flawed safe­ty assessment

Debate: What are the ethics of discouraging much-needed innovation given potential privacy concerns?

by

CNN’s Ana Maria Mon­tero inter­views Ned Sahin. The dis­cus­sion about the impact of EU pri­va­cy laws starts in minute 10.

Sto­ry descrip­tion (CNN Mon­ey): Ned Sahin is founder and CEO of neu­rotech­nol­o­gy start-up Brain Pow­er, whose tool “Empow­er Me” uses smart glass­es like Google Glass to coach those with autism. It helps school­child­ren learn social and cog­ni­tive skills and can even guide adults through an inter­view process. Brain Power’s prod­uct is sold to many schools in the U.S. but may nev­er make it to mar­ket in Switzer­land [Read more…] about Debate: What are the ethics of dis­cour­ag­ing much-need­ed inno­va­tion giv­en poten­tial pri­va­cy concerns?