EnlitenAI Inc

EnlitenAI develops Neuroliten, an FDA-registered Class I Software as a Medical Device (SaMD) platform for decision support in the treatment of neurological and neurobehavioral disorders. The platform specializes in seizure management for drug-resistant epilepsy and is designed to support clinical decision-making for conditions including autism spectrum disorder, PTSD, anxiety, depression, and Parkinson's disease. The system integrates multimodal data streams from FDA-cleared wearables and implantables to deliver personalized, data-driven treatment recommendations and drug-device titration guidance. Neuroliten was registered with the FDA on January 9, 2026, under OUG product code classification. The company operates with a device-agnostic architecture that translates patient-specific data into actionable clinical insights, moving away from trial-and-error approaches in neurological care. EnlitenAI's team includes clinical expertise from UCSF Neurology, computational sciences specialists, and digital health entrepreneurs. The platform is designed for use by neurologists, patients, caregivers, and pharmaceutical partners. The company follows a phased regulatory strategy with additional functionalities under development for future submission. Based in Tracy, California, with a regional office in the greater Sacramento area, EnlitenAI focuses on precision neurological and neurobehavioral care delivery.