As of today, Cell-Guardian has FDA Class I Clearance. This means the system can pick up and display data like Heart Rate, Respiration, and Temperature, but this data is for observational purposes and cannot be used to make formal medical decisions (e.g., charting it in a medical record).
Future Upgrades
Predictive Behavior (AI - e.g., Head Banging): December 2025.
Multi-Person Monitoring: February 2026. This will allow the system to also pick up incidents like fights and sexual assault.
Definitive Vitals (FDA Class II Clearance): March 2026. This clearance will allow the data to be used for formal medical decisions.
Key Selling Point for 2025:
Any contract signed in 2025 will receive the AI-Behavior and Multi-Person Monitoring upgrades for FREE.
Any contract signed in 2025 and beyond will receive the Definitive Vitals (Class II) upgrade for FREE.