BioPhia Consultant Ed Moore presents a training video as part of the Great Lakes Medical Jumpstart I-CORPS program discussing the regulatory paths associated with Artificial Intelligence/ Machine Learning or Software as a Medical Device (SaMD). Software as a Medical Device (SaMD) is a relatively new area of medical devices that is now regulated by the FDA Center for Devices and Radiological Health (CDRH). FDA partnered with regulatory authorities from other countries/regio