PatentNext Summary: The development of modern medical devices increasingly includes the use of software for performing sophisticated diagnostic or treatment-related functions. In fact, the U.S. Food and Drug Administration (FDA) now defines specific categories of software-based medical devices that include “Software as a Medical Device (SaMD)” and “Software in a Medical Device (SiMD).” In a similar way, courts review patents directed to software-based medical devices across several categories, which include inventions having “particular machines” (e.g., SiMD) and inventions purely involving software only (e.g., SaMD).

Continue Reading Patenting Software-based Medical Devices (Part 1)