Imaging Diagnostic Systems has submitted to the FDA the second module of its application for pre-market approval of its CT laser mammography (CTLM) system. The company said it anticipates finalizing the module submission process early this year.
The Plantation, FL-based firm has targeted the CTLM system for use as an adjunct to mammography in the detection of breast abnormalities. CTLM is a non-invasive procedure that does not expose the patient to radiation or require breast compression.
By AuntMinnie.com staff writersJanuary 3, 2001
Related Reading
CT laser mammography system nears European approval, December 6, 2000
Imaging Diagnostic gets more financing, August 21, 2000
IDS names medical director, May 18, 2000
IDSI bolsters financial position, February 23, 2000
Copyright © 2001 AuntMinnie.com
















![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&fit=crop&h=112&q=70&w=112)


