This study provides an updated landscape of FDA-approved AI/ML-enabled medical devices as of October 19, 2023. The analysis covers 691 devices, highlighting a significant surge in approvals since 2018, with radiology being the dominant specialty due to abundant clinical data. The majority (96.7%) of approvals were through the 510(k) pathway, based on substantial equivalence, while only 3% underwent clinical trials. The study also notes a lack of pediatric-focused devices and a geographical limitation in clinical trials, primarily within the United States. The analysis identifies trends, potential gaps, and areas for future exploration, including clinical trial practices and regulatory approaches. The findings contribute to a broader understanding of the current state and future directions of AI/ML-enabled medical devices.This study provides an updated landscape of FDA-approved AI/ML-enabled medical devices as of October 19, 2023. The analysis covers 691 devices, highlighting a significant surge in approvals since 2018, with radiology being the dominant specialty due to abundant clinical data. The majority (96.7%) of approvals were through the 510(k) pathway, based on substantial equivalence, while only 3% underwent clinical trials. The study also notes a lack of pediatric-focused devices and a geographical limitation in clinical trials, primarily within the United States. The analysis identifies trends, potential gaps, and areas for future exploration, including clinical trial practices and regulatory approaches. The findings contribute to a broader understanding of the current state and future directions of AI/ML-enabled medical devices.