AI developer HeartLung Technologies has received breakthrough medical device designation and marketing authorization from the U.S. Food and Drug Administration (FDA) for its Automated Cardiac Chambers Volumetry (AutoChamber) software.
AutoChamber reports the volume of cardiac chambers and left ventricular wall mass in noncontrast CT scans for coronary artery calcium (CAC) scoring and in lung scans for lung cancer screening. It also works on coronary CT angiography (CCTA) scans. By adding AutoChamber AI to CAC scans and analyzing both coronary artery plaque calcification and cardiac chamber volume, HeartLung plans to introduce AI-CAC and AI-CVD [cardiovascular disease] to advance preventive cardiology.
![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)
