Health tech experts caution FDA against waiving regulatory review of AI-based imaging tools

Healthcare technology experts are warning that a recent move by the U.S. Food & Drug Administration to eliminate regulatory review of some artificial intelligence tools, including imaging devices, may have detrimental effects.

Technology researchers, however, have stepped forward saying a careful review of AI is necessary, particularly given the “uneven” performances of such software, including those focused on breast imaging, according to a Jan. 16 story published by STAT.