Breast CT developer Koning has received U.S. Food and Drug Administration (FDA) approval for its breast CT scanner, including a biopsy bracket add-on.
Koning completed the FDA's premarket approval (PMA) process for the 3D breast CT scanner, as well as an optional biopsy bracket for CT-guided biopsies of suspicious breast lesions. Other optional accessories for the system include a collimator that limits the x-ray beam to the area of interest, according to the vendor.
More than 680 breast CT scans were performed at Elizabeth Wende Breast Care in Rochester, NY, and the University of Rochester Medical Center, with additional collaboration at the University of Massachusetts Medical Center in Worcester, MA, Koning said. A large reader study led by Dr. Etta Pisano was also conducted at the Medical University of South Carolina.
![Axial images from unenhanced calcium score cardiac CT (left) and curved planar reformation images from CT angiography (right) show that higher long-term exposure to air pollution is associated with greater coronary artery calcium and more obstructive coronary artery disease (CAD). Top row: Images in a 68-year-old male patient with higher 10-year mean ambient air pollution exposure (7.9 μg/m3 for particulate matter measuring ≤2.5 μm in diameter [PM2.5] and 17.4 parts per billion [ppb] for NO2) with extensive CAD (coronary artery calcium score [CACS] >1,000 and obstructive CAD [≥70% diameter stenosis]). Bottom row: Images in a 57-year-old female patient with lower 10-year mean ambient air pollution exposure (6.3 μg/m3 for PM2.5 and 4.6 ppb for NO2) with no CAD (CACS = 0 and no obstructive stenosis).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/06/hanneman.r6SMLzkezo.png?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
