CT laser mammography developer (CTLM) Imaging Diagnostic Systems has been notified by the Medical Device Bureau of Health Canada that its application for a new medical device license has been approved.
With the news, the Plantation, FL-based vendor will be able to sell its CTLM system in Canada. The firm’s pre-market approval (PMA) application is pending with the U.S. Food and Drug Administration.
By AuntMinnie.com staff writersNovember 14, 2003
Related Reading
IDSI PMA judged suitable for filing, June 18, 2003
Imaging Diagnostic Systems receives 12th U.S. patent, May 29, 2003
Imaging Diagnostic Systems files PMA, April 30, 2003
Imaging Diagnostic Systems adds Berlin site, February 3, 2003
IMDS nets CTLM deal in Dubai, January 23, 2003
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![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)






