An advisory committee to the FDA recommended Dec. 10 against the approval of an optical imaging technology being developed by Computerized Thermal Imaging (Portland, OR). The FDA's Radiological Devices Panel voted 4 to 3 that the FDA deny approval of the
An advisory committee to the FDA recommended Dec. 10 against the approval of an optical imaging technology being developed by Computerized Thermal Imaging (Portland, OR). The FDA's Radiological Devices Panel voted 4 to 3 that the FDA deny approval of the company's infrared breast imaging system. Panel members described the technology as promising but decided more clinical data were necessary for members to recommend approval. The FDA has yet to decide on the matter.
Mammography Study Compares False Positives Between AI and Radiologists in DBT Screening
May 8th 2025For DBT breast cancer screening, 47 percent of radiologist-only flagged false positives involved mass presentations whereas 40 percent of AI-only flagged false positive cases involved benign calcifications, according to research presented at the recent American Roentgen Ray Society (ARRS) conference.