FDA-Registered.
digitalhumanOS™ is from an FDA-registered medical device establishment. It is intended to support clinical decision-making by healthcare providers through multimodal clinical screening of speech biomarkers and visual indicators.
Key Facts
- Status
- FDA-Registered
- Establishment
- Registered
- Conditions
- 46
- Compliance
- HIPAA
- Deployment
- Samsung Knox
FDA-registered. HIPAA compliant. Human-in-the-loop by design. Because trust in healthcare is not a feature. It is a prerequisite.
This content is intended for informational purposes and does not constitute medical advice. Editorially reviewed by David Kaiser, CEO of Scienza Health, for accuracy in post-acute care operations.
What FDA Device Establishment Registration Means for Your Health System
FDA device establishment registration means that the facility manufacturing or distributing the medical device has registered with the FDA and listed its devices. Scienza Health's establishment is registered as a medical device establishment, confirming FDA oversight of the manufacturing and distribution process.
For health systems evaluating clinical screening technology, establishment registration provides confirmation that the platform operates within the FDA's regulatory framework for medical devices.
Peer-Reviewed. Clinically Validated.
Our screening models aren't validated on curated lab data. They are validated against real clinical outcomes from real patients in real care settings. Depression screening at 81.6% accuracy (Journal of Affective Disorders). PTSD at 80.0% (Journal of Traumatic Stress). Anxiety at 77.5% (Psychological Medicine). Parkinson's at an AUC of 0.97 (Movement Disorders). These numbers come from peer-reviewed clinical research — not marketing claims.
Safety Is Not a Feature. It Is the Foundation.
GIA®, powered by digitalhumanOS™, is a screening agent — not a diagnostic tool. She flags potential conditions for clinician review. Every result is reviewed by a qualified healthcare provider before any clinical action is taken. The system assists clinical judgment. It never replaces it.
digitalhumanOS™ does not diagnose, treat, cure, or prevent any disease or condition. All screening results require review and clinical judgment by a qualified healthcare professional before any clinical action is taken.
For medical directors and compliance officers evaluating GIA® for clinical deployment. See how GIA® integrates with PointClickCare, Epic, Cerner, and MatrixCare.
Screening, Not Diagnosis
Every flagged condition requires clinician confirmation. The system identifies what needs attention — the clinician decides what to do about it.
Continuous Monitoring
Model performance is monitored continuously against real-world outcomes. Accuracy doesn’t degrade because we catch it before it does.
Transparent Methodology
Our clinical validation methodology, accuracy metrics, and limitations are published and peer-reviewed. We don’t ask for trust. We earn it.