Preview: Mammography rallies on political leap forward

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.