Comment from Vivalink
AnonymousSupportBusiness
Summary: VivaLink, Inc., a medical-grade wearable biosensor and connected-health platform company, supports the FDA's proposed pilot program for AI-enabled clinical trials. They recommend prioritizing continuous safety monitoring, establishing real-time data infrastructure standards, and ensuring equitable participation through risk- and competence-based selection criteria.
VivaLink, Inc. appreciates the opportunity to provide comments on the U.S. Food and Drug Administration's Request for Information regarding the AI-Enabled Optimization of Early-Phase Clinical Trials Pilot Program (Docket No. FDA-2026-N-4390).
The attached comments reflect VivaLink's experience supporting decentralized and AI/DHT-enabled clinical trials using continuous physiological monitoring. We hope these recommendations contribute to the development of a practical, scalable, and safe pilot program.