Autonomous Medical Safety for Unwitnessed Collapse
A clinician-prescribed, physiology-gated implantable system designed to initiate emergency response only when catastrophic medical instability persists.
Unwitnessed Incapacitation Changes the Risk Standard
Emergency systems often assume conscious awareness, physical mobility, and the ability to activate a response. Unwitnessed collapse removes those assumptions.
- Sudden cardiac instability
- Seizure-related loss of consciousness
- Hard falls followed by physiologic decline
- Incapacity without phone or wearable access
In these moments, detection alone is insufficient. Escalation discipline becomes the defining design variable.
Physiology-Gated Escalation Architecture
Stage A — Event Detection
Impact or collapse pattern initiates evaluation. Detection does not equal emergency.
Stage B — Physiologic Validation
Cardiovascular or perfusion instability is assessed during defined low-motion windows.
Stage C — Escalation
Emergency signaling occurs only if sustained instability persists beyond predefined thresholds.
The AI is intentionally constrained — it performs inference within predefined, safety-governed logic and cannot evolve or act independently in the field.
Differentiation
| Consumer Safety Systems | FallGuardAI |
|---|---|
| User-dependent activation | Autonomous detection |
| Motion-triggered alerts | Physiology-validated escalation |
| Continuous connectivity reliance | Event-gated signaling |
| Adaptive consumer AI | Constrained, safety-governed logic |
Regulatory & Governance
- FDA Pre-Submission completed
- ISO 14971-aligned risk management framework
- No in-field AI self-evolution
- Auditable decision traceability
- Clinician authority preserved
- NIH SBIR pathway
FallGuardAI is under development and not available for commercial sale. Subject to regulatory review and approval.
Clinical Collaboration
FallGuardAI seeks collaboration across neurology, cardiology, electrophysiology, emergency medicine, and EMS disciplines.
Areas of engagement include escalation threshold review, physiologic validation parameters, and failure mode evaluation.
Contact
Clinical Inquiry — Threshold validation and deployment frameworks
Regulatory Inquiry — Institutional or agency correspondence
Engineering Collaboration — Technical architecture engagement
Strategic Partnership — Regulated ecosystem alignment
Email: info@fallguardai.com