Hologic nears commercialization of breast tomosynthesis
Hologic has pursued breast tomosynthesis as a commercial modality for the last five years, recruiting luminaries with track records in tomo going back a decade or more. Now, at RSNA 2010, the company is on the brink of achieving that objective.
Hologic has pursued breast tomosynthesis as a commercial modality for the last five years, recruiting luminaries with track records in tomo going back a decade or more. Now, at RSNA 2010, the company is on the brink of achieving that objective.
The Selenia Dimensions system shown in the Hologic booth remains a work-in-progress for breast tomosynthesis, requiring the company to refrain from marketing the system for its 3D capabilities. But in the week leading up to the meeting, Hologic received an approvable letter from the FDA for those capabilities. All that remains before this system can be marketed in the U.S. for tomosynthesis is a positive review and inspection by the FDA of the manufacturing facility, methods, and controls that Hologic has put in place to produce the tomosynthesis device. Hologic plans to schedule this inspection in the coming weeks.
Selenia Dimensions systems, built to do tomosynthesis, have been rolling off the company’s production line for more than two years. Hundreds have landed in Europe, Canada, and Mexico. A few have found homes in the U.S., but only as 2D digital mammography systems. Converting them to 3D requires nothing more than a simple software upgrade, accomplished remotely, which Hologic will be more than happy to provide as soon as the FDA says it can do so.
AI-Initiated Recalls After Screening Mammography Demonstrate Higher PPV for Breast Cancer
March 18th 2025While recalls initiated by one of two reviewing radiologists after screening mammography were nearly 10 percent higher than recalls initiated by an AI software, the AI-initiated recalls had an 85 percent higher positive predictive value for breast cancer, according to a new study.
ECR Mammography Study: Pre-Op CEM Detects 34 Percent More Multifocal Masses than Mammography
February 28th 2025In addition to contrast-enhanced mammography (CEM) demonstrating over a 90 percent detection rate for multifocal masses, researchers found that no significant difference between histological measurements and CEM, according to study findings presented at the European Congress of Radiology.
Study: Mammography AI Leads to 29 Percent Increase in Breast Cancer Detection
February 5th 2025Use of the mammography AI software had a nearly equivalent false positive rate as unassisted radiologist interpretation and resulted in a 44 percent reduction in screen reading workload, according to findings from a randomized controlled trial involving over 105,000 women.
