FDA Challenges WHOOP Over Blood Pressure Insights

In July 2025 WHOOP received an FDA warning over its Blood Pressure Insights (BPI) feature, and the dispute culminated in new FDA wellness guidance issued January 6, 2026. The article reviews the FDA's arguments—'inherent association', language and interface concerns—and WHOOP's responses, noting ambiguous wellness exemptions and implications for wearable makers seeking to report biomarker data without medical-device classification.