digitalhumanOS™ is a 510(k) registered clinical screening platform. It is intended to support clinical decision-making by healthcare providers through multimodal screening of speech biomarkers and visual indicators. 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. GIA™ is a trademark of Scienza Health, Inc. Digital Human® is a registered trademark of Scienza Health, Inc. Samsung, Galaxy, Knox, and DeX are trademarks of Samsung Electronics Co., Ltd. All other trademarks are the property of their respective owners. Product specifications, accuracy figures, and regulatory status are subject to change. For the most current information, contact Scienza Health directly.
510(k) registration indicates that the FDA has reviewed the device for substantial equivalence to a legally marketed predicate device. It does not constitute FDA approval or endorsement of the device's safety or effectiveness for any specific indication. HIPAA compliance refers to Scienza Health's adherence to the Health Insurance Portability and Accountability Act requirements for protecting health information.
