Biosensors & Diagnostics

Biosensors and diagnostics extend from continuous glucose monitoring to multi-cancer early detection with multiple FDA breakthrough designations. The session covers continuous biosensors for cortisol, ketones and lactate, point-of-care diagnostics including paper-based assays, lab-on-a-chip platforms, wearable biosensors (Levels, Veri, Ultrahuman), the FDA breakthrough-device pathway, and the integration of biosensor data into clinical decision-making. Discussion addresses CGM in non-diabetic populations including obesity and sports performance, biosensor accuracy claims and regulatory scrutiny, the equity and access implications, biosensor data privacy under HIPAA and GDPR, and emerging targets including continuous hormones and inflammatory biomarkers.