Scienza Health Achieves 510(k) Clearance for digitalhumanOS™ Clinical Screening Platform

NEWPORT BEACH, CA — Scienza Health today announced that the U.S. Food and Drug Administration has granted 510(k) clearance for the digitalhumanOS™ platform, validating the company’s multimodal clinical screening technology for cognitive, neurological, and behavioral health conditions in post-acute and long-term care environments.

The 510(k) clearance establishes digitalhumanOS™ as the regulatory foundation for GIA®, Scienza’s digital human that conducts clinical screening conversations with patients. The clearance covers the platform’s use of Voice AI, Computer Vision, and Speech Biomarker analysis to identify clinical indicators during patient interactions.

Peer-reviewed accuracy benchmarks include Depression at 81.6%, PTSD at 80.0%, Anxiety at 77.5%, and Parkinson’s at AUC 0.97. The platform is trained on 12.3 million longitudinal PAC/LTC patient records and 27 billion clinical events.

"The 510(k) is not a marketing milestone. It is the regulatory line between a wellness app and a clinical screening platform," said David Kaiser, Founder & CEO of Scienza Health. "Every claim we make about GIA®’s screening capabilities is backed by this clearance. When a Director of Nursing asks whether she can trust the results, the answer is not a pitch deck — it is a 510(k) clearance number."

The platform operates within a 5-layer governance framework that includes mandatory human-in-the-loop review before any screening result enters the clinical record. GIA® delivers results to the clinician; the clinician makes the clinical decision.

Forward-looking statements: This release contains forward-looking statements about the platform’s intended use and clinical applications. Actual results may differ.

Media contact: press@scienzahealth.com