The technology formerly known as picture archiving and communication systems (PACS) will now be referred to as MIMPS, or medical image management and processing systems, according to new classifications from the U.S. Food and Drug Administration (FDA).
The FDA amended the descriptions for three radiology software functions to align more accurately with recent regulatory changes. The changes, which were announced April 19, are effective immediately and can be read in full in the Federal Register. The final rule outlines a total of eight software functions previously classified as medical devices under the 21st Century Cures Act.
As reported in Health Imaging, the MIMPS description now excludes software functions for the storage and display of medical images. According to the FDA, the software components may provide “advanced or complex image processing functions for image manipulation enhancement, or quantification that are intended for use in the interpretation and analysis of medical images.”
The rule also states that advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
To learn more, see the final rule in the Federal Register here or read the Health Imaging article here.