Hologic (NSDQ:HOLX) said today it won FDA premarket approval to add Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology to its 3Dimensions breast tomosynthesis machines.
With the new approval, the Marlborough, Mass.-based company said its system provides enhanced resolution 3D imaging which it touts as the industry’s fastest, highest resolution 3D images.
Images through the newly cleared applications are designed to show subtle lesions and fine calcifications for earlier cancer diagnoses.
“The passion that fueled our efforts to establish the Genius exam as the standard of care continues to drive us forward as we develop bold and innovative technologies optimized for superior performance for a diverse population of women. The 3Dimensions system represents a major breakthrough in breast cancer screening technology because it offers unprecedented image clarity regardless of breast size or density, increased comfort, and the reliable accuracy our customers have come to expect from Hologic products. We’re proud to introduce this new product, which serves as yet another example of why Hologic is the partner of choice for clinicians globally,” breast and skeletal health solutions prez Pete Valenti said in a prepared statement.
The newly cleared Clarity HD tech includes an advanced detector and a 3D imaging algorithm designed to improve 3D imaging quality, regardless of breast size or density.
“Our experience as a leader in breast cancer screening has taught us that radiologists and technologists value accuracy above all else. We developed the 3Dimensions system with that in mind, while adding two features that have great potential to improve patient satisfaction,” breast and skeletal health solutions R&D global VP Tracy Accardi said in a prepared release.
Earlier this month, Royal Philips (NYSE:PHG) and Hologic inked a deal to integrate Hologic’s mammography technologies into the Dutch healthcare giant’s imaging portfolio.
