Clarifying the grey zone: a proposal
CFG proposes a new EU governance category for wellness neurotechnology devices and sets out what it would take to make it work.
Neurotech between wellness and medicine
The rapid growth of wellness neurotechnologies is revealing a regulatory grey zone between medical and consumer markets. These devices operate at the intersection of strong commercial incentives, pressing public health needs, and regulatory frameworks designed for a time when the boundary between medical and consumer products was far clearer. In this series of articles, CFG examines that tension from multiple perspectives, concluding with a proposal for how regulators can respond to support ethical innovation.
Articles in this series
How neurotech companies navigate the grey zone
The line between a wellness device and a medical one is harder to draw than regulators assume. CFG spoke to founders and experts about the strategic pressures shaping that choice, and what they want policymakers to do about it.
Promise and peril in wellness neurotech
We reviewed more than a hundred wellness neurotechnology company websites — examining their marketing claims, the evidence behind them, and what they do or don't disclose about regulatory status.
Introducing “Neurotech between wellness and medicine”
Consumer neurotechnology devices are multiplying fast — and slipping through the gap between medical regulation and the consumer market. CFG examines the tensions driving this grey zone, and what regulators can do about it.