Innovation in central nervous system (CNS) care is extending beyond traditional drug development.
This article, co-authored by CRA’s Will Foster and Juliette Richards, explores how advances in artificial intelligence (AI), data collection, and connected technologies are enabling new approaches to diagnosing, monitoring, and treating neurological and psychiatric conditions.
Much of this momentum is concentrated in three areas: brain-computer interfaces (BCIs), wearable technologies, and digital health software. Together, they offer life sciences companies opportunities to reach underserved patient populations, strengthen CNS portfolios, and support more personalized care.
Below is a summary of the three key findings addressed by the authors.
1. AI is improving the performance and accessibility of brain-computer interfaces
BCIs are advancing beyond the historical trade-off between the precision of surgically implanted systems and the accessibility of non-invasive alternatives. AI-enabled adaptive stimulation, minimally invasive implantation methods, and improved neural-signal decoding are helping developers enhance performance while reducing barriers to patient adoption.
Greater regulatory clarity is also supporting clinical development, with several BCI developers receiving Investigational Device Exemption approval following US Food and Drug Administration guidance issued in 2021.
2. Wearables offer more immediate opportunities to reshape CNS care
Consumer and prescription-grade wearables are enabling more continuous approaches to detecting, monitoring, and treating CNS conditions. Data from smartphones and smartwatches are being studied for the early identification of cognitive and neurological changes, while specialized devices can detect seizures, monitor neural activity, or deliver neuromodulation outside traditional clinical settings.
For manufacturers, wearables may provide an accessible route to improve patient management, differentiate existing portfolios, and generate insights across the care pathway.
3. Digital health software needs clear Commercialization and Value creation strategies
Digital health applications continue to offer scalable and accessible interventions, including psychotherapy-based treatments that can complement or reduce reliance on pharmacotherapy. However, regulatory approval and clinician interest do not necessarily translate into commercial success.
Persistent challenges include uncertain reimbursement pathways, payer concerns about cost-effectiveness, and limited real-world evidence. Developers will need to demonstrate not only clinical benefit, but also measurable economic value and a credible path to coverage.
The authors conclude that as technology-enabled interventions gain traction, life sciences companies should assess where BCIs, wearables, and digital health software could complement existing or pipeline assets.
