Press Release: Brain-sensing wearables surge into regulatory grey zone, new analysis warns

BRUSSELS — Consumer neurotechnology companies now outnumber their medical counterparts globally, with 153 firms developing neural interfacing wearables and wellness devices compared to 118 focused on medical applications, according to new research by the Centre for Future Generations (CFG).

The comprehensive analysis of 271 neurotechnology companies reveals a market transformation accelerating towards consumer applications since 2018, bolstered in part  by artificial intelligence and miniaturisation. Applications range from “Fitbit for the brain” wellness trackers to cognitive performance boosters integrated into earbuds and glasses.

“We’re witnessing the mainstreaming of neurotechnology,” said Virginia Mahieu, Neurotech Programme Director at Centre for Future Generations. “What began in targeted medical diagnostics has exploded into a diverse consumer ecosystem where brain data is collected outside traditional healthcare safeguards. This raises urgent questions about data privacy and regulatory oversight.”

The report, ‘Mapping the emerging consumer neurotechnology market landscape’, identifies electroencephalography (EEG) as the dominant technology, used by nearly 65% of consumer firms due to its portability, safety, and exemption from medical device regulations. AI has emerged as the second-most prevalent technology, enabling real-time mental state feedback and personalised wellness recommendations.

Regional differences shape market specialisation:

• North America (48% of companies): Dominated by wellness and fitness applications, with stronger venture capital backing
• Europe (38% of companies): Led by research-grade tools, with more balanced public-private funding
• Consumer firms bring products to market faster: 52% have launched products compared to just 40% of medical companies

The analysis reveals concerning regulatory gaps as many consumer neurotechnology companies operate in a “grey zone” between wellness claims and medical applications. Companies leverage health-adjacent messaging (e.g. “Reduce stress in four minutes,” “Mental health care for everyone”) while avoiding the clinical trials required for medical devices.

“Big Tech is circling,” noted Laura Bernáez Timón, Fellow at CFG. “Apple has patented EEG AirPods, Meta acquired neural interface startup CTRL-Labs, and Samsung has invested in neural wristbands. This suggests brain-sensing capabilities could soon be seamlessly integrated into the world’s most widely used devices.”

The research comes as the EU implements new AI regulations that may affect consumer neurotechnology applications involving emotion recognition and cognitive profiling — areas where many consumer neurotech companies currently operate without oversight.

CFG’s analysis highlights the need for anticipatory governance as consumer neurotechnology transitions from niche innovation to pervasive digital infrastructure, potentially reshaping how Europeans work, rest, and interact with technology.

Read the full report here.

—ENDS—