FDA-Regulated Digital Therapeutic for Anxiety Disorders
Evidence-Based CBT • Biofeedback Integration • Clinical Monitoring
Scientifically validated protocols for anxiety disorders
Wearable integration for physiological monitoring
Professional monitoring and automatic risk escalation
This is a demonstration MVP for the FDA TEMPO program (January 2026). The application implements evidence-based CBT protocols, biofeedback integration, and clinical monitoring in compliance with FDA 21 CFR Part 11, HIPAA, and ISO 13485.
⚕️ Medical Device Information
ANXI Clinical is a Class II medical device candidate under FDA TEMPO review (21 CFR 882.5050 - Biofeedback Device). This system is investigational and not intended to replace professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition.
FDA TEMPO Application: January 2026 • Regulatory Status: Investigational Device