Replies to post #5413 on Foxo Technologies Inc (FOXO)

[Fire_starter]

US Patent 11817214, titled "Machine learning model trained to determine a biochemical state and/or medical condition associated with a subject", relates to using machine learning (ML) models to analyze epigenetic data and predict medical conditions.
Overview of Patent 11817214
Title: Machine learning model trained to determine a biochemical state and/or medical condition associated with a subject.
Core Technology: The patent describes systems and methods for training ML models to receive epigenetic data as input and output a classification of a subject's biochemical state or medical condition.
Application: This technology could be used to identify new uses for existing pharmaceutical compounds or screen new molecules for treating target diseases, as well as for diagnostic purposes.
Assignee: The patent is assigned to the Regents of the University of California and the United States of America as represented by the Secretary of Health and Human Services.
Connection to the FDA
The user mentions the FDA in their query, which likely refers to the regulatory aspects of such technology. The FDA does not "title" or issue patents; patents are issued by the United States Patent and Trademark Office (USPTO).
However, any medical device software or system using this patented technology for a clinical purpose (e.g., diagnosis, treatment recommendation) would fall under the FDA's regulatory framework for Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).
The FDA has established specific guidance for the development and marketing of AI/ML-enabled devices, including:
Good Machine Learning Practice (GMLP) principles for medical device development.
Recommendations for marketing submissions using a Predetermined Change Control Plan (PCCP) to manage iterative changes to algorithms.
A public list of FDA-authorized AI/ML-enabled medical devices to promote transparency.
Therefore, while the patent itself is a USPTO document, the commercial application of the technology described would need to adhere to relevant FDA regulations to be legally marketed as a medical device in the U.S.