Scienza Health announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) registration and listing for the DigitalHumanOS™ platform, marking it as the first AI-powered Digital Human system to achieve this regulatory milestone as a Class II medical device.
The FDA 510(k) registration and listing validates Scienza's nine specialized Digital Humans™ for use in clinical environments, including patient screening, documentation, and care coordination. The platform demonstrated 94% diagnostic accuracy in clinical trials involving over 11 million patient interactions.
"This FDA 510(k) registration and listing represents a watershed moment for AI in healthcare," said Dr. George Mastorakos, Chief Medical AI Officer. "It validates our rigorous approach to developing clinically-proven AI that meets the highest regulatory standards while delivering measurable improvements in patient outcomes."
