The technological and political evolution of digital mammography will be in evidence on the RSNA exhibit floor.
The technological and political evolution of digital mammography will be in evidence on the RSNA exhibit floor.
With September’s unanimous finding by the FDA’s Radiological Devices Panel that Hologic's digital mammography tomosynthesis system is effective and safe, Hologic is in position to cautiously present Selenia Dimensions at the RSNA meeting as the digital mammography solution of the future. The system is already sold outside the U.S. for volumetric use and in the U.S. for 2D application. If FDA reviewers agree with their advisory panel and remaining issues are worked out with Hologic, Selenia Dimensions could be on the U.S. market as a breast tomo product early next year.
A few weeks later, the FDA approved Carestream’s DirectView computed radiography system for use in mammography. Once the FDA approves the final labeling, Carestream can begin commercially distributing its CR mammography product, as well as upgrading existing CR units in the field to mammo capability. A simple software upgrade and special mammo-compatible phosphor plates are all that will be needed.
Almost as if the FDA were finishing off its workload before embarking on a new political direction, Selenia Dimensions and DirectView CR became the last two mammography products to navigate the agency’s class III regulatory maze, which has for so long held full-field digital mammography (FFDM) to the strictest requirements of any medical device in order to receive clearance. In late October, on the heels of the Carestream device’s approval, the agency downgraded FFDM to class II.
Since the first FFDM device, GE’s Senographe 2000D, passed FDA muster nearly 11 years ago, every FFDM device has had to go through the premarket approval system, a lengthy and often torturous process nearly as rigorous as the drug approval process.
In a statement displaying the caution exercised by this country’s regulatory watchdog, the FDA noted that digital mammography systems had been categorized as “high-risk” devices for more than a decade. But since their first issue, digital mammography has been well validated in scientific studies involving tens of thousands of patients, according to the FDA, and they now can be reclassified from class III to class II, medium-risk devices.
FFDM products from this point on can look forward to a much simpler review. To ease the transition to this new process, the FDA released a special controls guidance for industry that describes what evidence will be needed to show substantial equivalence for these systems, including technical device specifications, images of standard test objects, and a sample set of patient images.
With this change, FFDM products on worldwide markets outside the U.S. might finally and quickly gain access to U.S. customers. The change couldn’t come at a better time for Sectra, which at this year’s RSNA meeting will be pushing its Sectra MicroDose Mammography systems as part of a global financial initiative. The company hopes to boost its profit margin to at least 15% and achieve 15% annual growth over a seven-year period, at least partly on increased sales of its MicroDose Mammography product, which has yet to enter the U.S. market.
To meet those goals, market share and sales volumes of the mammography product must increase, according to the company. Version 8.3, scheduled to be unveiled at the show, will grease the financial skids. This version will include a laser-based needle examination add-on to localize lesions for preoperative planning, detector enhancements that increase dose efficiency and image quality, and support for remote monitoring to improve proactive service.
Is the Kaiser Score More Effective than BI-RADS for Assessing Contrast-Enhanced Mammography and MRI?
October 14th 2024For women with breast-enhanced masses, Kaiser scoring (KS) demonstrated a 20 percent higher AUC than BI-RADS classification for contrast-enhanced mammography (CEM) and was comparable to KS for breast MRI.
FDA Clears New Features in AI-Powered Mammography Software Suite
October 11th 2024Therapixel’s MammoScreen suite has received 510(k) FDA clearances for a breast density assessment feature and updated software that includes automated pre-reporting, which reportedly expedites reporting of mammography findings.
Multicenter Study Identifies Key Factors Associated with Mammogram-Occult Ipsilateral Breast Cancer
October 9th 2024A symptomatic first breast cancer diagnosis, prevailing breast density at a second breast cancer diagnosis and trabecular thickening on surveillance mammography were linked to mammogram-occult ipsilateral breast cancer, according to new research.
Radiology Experience, Breast Density and Screening Mammography: What New Research Reveals
October 4th 2024In a study looking at the impact of experience and case volume of breast screening radiologists, researchers found that reviewing more than 150 cases per week was necessary to achieve an 80 percent rate of true-positive assessments for malignant calcifications.