Facilitating Safe Access via Technology-Assistance.
ACNU: Convenience + Accessibility.
Consumers are seeking healthcare solutions that align with their dynamic lifestyles, prioritizing convenience and accessibility. This cultural shift is supported by advancements in wearables, AI diagnostics, and virtual healthcare settings.
ACNU, or Additional Condition for Nonprescription Use, is a recently finalized FDA rule that safely expands access to nonprescription drugs by incorporating a tech-assisted companion for automated, real-time clinical decision support.
Expanding OTC availability reduces costs, improves adherence and empowers individuals to manage chronic conditions with fewer barriers.
CodeScripts is built to the SaMD standard and specifically designed for ACNU programs.
TACTiC Trial '24
Tech-Assisted Cholesterol Trial in Consumers.
In the recent Technology-Assisted Cholesterol Trial in Consumers (TACTiC), sponsored by AstraZeneca, our device successfully demonstrated that participants could safely and effectively select, acquire and use rosuvastatin calcium 5-mg over a six-month period, suggesting that technology-assisted self-management of statins is feasible.
CodeScripts.
Pioneering ACNU Programs by Connecting Drugs to Digital Care.
Power to Launch.
CodeScripts is purpose-built for ACNU programs, offering pre-configured features and compliance tools to reduce costs and accelerate FDA approval.
Proven Self-Selection Technology.
Our self-selection technology, validated in multiple successful studies, minimizes time while ensuring safe and effective outcomes.
Regulatory Excellence.
CodeScripts adheres to SaMD standards, ensuring seamless regulatory compliance.