California-based Box Inc. announced recently that the FDA has cleared the company’s DICOM Viewer as a Class II Medical device. DICOM, which stands for Digital Imaging and Communications in Medicine, is the standard for the communication and management of medical imaging information and related data. The standard was developed in the early 1980s and facilitates communication of digital image information from imaging modalities such as CT scans, MRIs, ultrasounds, and x-rays. According to Box’s website, the Box DICOM Viewer allows users to store, view, and share DICOM images from the web or any mobile device.
Box made the FDA clearance announcement during the Healthcare Information and Management Systems Society (HIMSS) Conference that was held in Las Vegas, Nevada. This year’s HIMMS Conference attracted over 45,000 persons from 75 countries, with over 1200 companies attending as well. This large attendance reflects a high level of interest in healthcare-related information technology (IT), which is not surprising given a recent prediction that FDA-regulated digital health solutions are expected to save the U.S. healthcare system more than $100 billion over the next four years. Analysts also predict that FDA approvals of digital health solutions will triple to 100 by the end of 2018, up from 33 in 2015.
One way that the FDA “clears” a medical device is when the device is found to be “substantially equivalent” to a device that has already been “approved” by the FDA. Here, Box’s DICOM Viewer was predicated on an FDA-approved picture archiving and communication system (PACS) that was developed by Clariso, Inc., which now operates as a subsidiary of Box.