U.K. software developer Ultromics has entered an agreement with Pfizer to expedite marketing clearance in the U.S. for its AI algorithm for detecting cardiac amyloidosis.
Under the partnership with Pfizer, Ultromics will research and pursue U.S. Food and Drug Administration (FDA) clearance for its EchoGo Amyloidosis algorithm. The software has already received Breakthrough Device designation from the FDA for the detection of cardiac amyloidosis. The algorithm uses deep learning to analyze routine ultrasound scans of the heart (echocardiograms) to detect disease that often goes undetected during standard assessments, Ultromics said.
![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&dpr=2&fit=crop&h=167&q=70&w=250)
