Purpose To provide an overview of the types of adverse events reported to the US Food and Drug Administration (US FDA) for magnetic resonance (MR) systems over a 10‐yr period. Methods Two reviewers independently reviewed adverse events reported to FDA for MR systems from 1 January 2008 to 31 December 2017 and manually categorized events into eight event types. Thermal events were further subcategorized by probable cause. Objects that became projectiles were also categorized. Results FDA received 1568 adverse event reports for MR systems between 1 January 2008 and 31 December 2017. This analysis included 1548 reports. Thermal events were the most commonly reported serious injury (59% of analyzed reports). Mechanical events — defined as slips, falls, crush injuries, broken bones, and cuts; musculoskeletal injuries from lifting or movement of the device — (11%), projectile events (9%), and acoustic events (6%) were also observed. Conclusions Adverse events related to MR systems consistent with the known hazards of the MR environment continue to be reported to FDA. Increased awareness of the types of adverse events occurring for MR imaging systems is important for prevention.

We summarize research and development for the extraction and distribution of biomedical information from a collection of 17,000 spine x-ray images collected by the second National Health and Nutrition Examination Survey (NHANES II). We present a history of the technical milestones of this work, including the data collection as film, digitization, quality control, archiving technology, database organization, medical expert content evaluation, and Web data distribution. We conclude by presenting our current work in content-based image retrieval (CBIR) to exploit the information content of these images directly by using image processing. We provide an overview and current research results from this CBIR work, which includes: extensive segmentation research, focusing on Active Shape Modeling and Active Contour methods; alternative techniques for shape representation, including invariant moments, simple polygon approximation, and Fourier descriptors; neural network classification of shapes into biomedical categories, such as "anterior osteophytes present/not present"; and the implementation of a prototype CBIR system for the vertebrae that supports hybrid text/image queries using MATLAB and the MySQL relational database system.

Functional magnetic resonance imaging (fMRI) experiments investigating cortical activity while controlling task performance are difficult to conduct due to the high magnetic field environment and a lack of compatible measurement tools. We describe a method to measure the generation of isometric shoulder and elbow torques with a six-degrees-of-freedom (DOF) load cell during an event-related fMRI study. Feasibility of this method is demonstrated by finding cortical activity on the motor cortices in a participant during an event-related study of shoulder abduction and elbow flexion. The described methodology permits researchers to control and measure intersubject and intrasubject motor task performance during event-related brain imaging.

Although there has been a resurgence of interest in low field magnetic resonance imaging (MRI) systems in recent years, low field MRI is not a new concept. FDA has a long history of evaluating the safety and effectiveness of MRI systems encompassing a wide range of field strengths. Many systems seeking marketing authorization today include new technological features (such as artificial intelligence), but this does not fundamentally change the regulatory paradigm for MR systems. In this review, we discuss some of the US regulatory considerations for low field magnetic resonance imaging (MRI) systems, including applicability of existing laws and regulations and how the U.S. Food and Drug Administration (FDA) evaluates low field MRI systems for market authorization. We also discuss regulatory considerations in the review of low field MRI systems incorporating novel AI technology. We foresee that MRI systems of all field strengths intended for general diagnostic use will continue to be evaluated for marketing clearance by the metric of substantial equivalence set forth in the premarket notification pathway.