Artificial Intelligence (AI) and Machine Learning (ML) are reshaping the world of Software as a Medical Device (SaMD), bringing a new level of intelligence and efficiency to healthcare. SaMD refers to software designed for medical purposes that doesn’t rely on physical hardware. When integrated with AI/ML, these software applications can analyze vast amounts of data, detect complex patterns, and continuously improve over time. This fusion is unlocking powerful applications across various fields, like enhancing radiology with advanced image analysis, detecting arrhythmias in cardiology, and supporting tumor detection and treatment planning in oncology. With AI-enabled ...