FDA clears CCD-based digital mammography device

Hologic exec declares new product DOA

Just as one arm of Hologic prepares to begin marketing the company's finally approved full-field digital mammography system, another is preparing to make the product obsolete. Hologic announced FDA approval for the CCD-based Lorad device last week, but in the same breath stated that the company is closing in on Lorad's replacement, a second-generation system based on amorphous selenium technology.

"The focus clearly is on the selenium system and not on the charge-coupled device," said Jack Cumming, president and CEO of Hologic. "Our expectations are that there's going to be limited emphasis on the CCD system. The inherent properties of selenium just lend themselves better to mammography."

Hologic's commitment to selenium-based digital mammography is no secret. At the RSNA meeting last November, the company revealed an alliance with Siemens to jointly develop such a product. Siemens exhibited Hologic's work-in-progress digital mammography detector based on amorphous selenium technology, and Hologic ran Siemens software in its digital mammography workstation. The prototype of a functioning digital mammography system, dubbed Selenia, appeared at the European Congress of Radiology in early March.

Meanwhile, the CCD-based system lumbered toward obscurity under the weight of a protracted review process at the FDA. It was first submitted for review-by Trex, its developer-in 1997. After almost two years of wrangling, the agency rejected the system as "not equivalent" to analog units (SCAN 8/18/99), the standard to which 510(k) applications for digital mammography systems were being held at the time. (Vendors have since submitted their applications for digital mammography systems to the FDA seeking premarket approval rather than 510(k) clearance, following GE Medical Systems' success with that process [SCAN 2/16/00].)

Rocky financial times and fallout from the FDA debacle proved too much for Trex. A fire sale of its assets (SCAN 8/30/00) brought the CCD-based Lorad technology to Hologic, which had also purchased Direct Radiography Corp. and its selenium-based technology from Sterling Diagnostic.

It is now clear that the selenium-based system has won out. In announcing FDA clearance of the Lorad system, Hologic noted that its second-generation Selenia work-in-progress is in the final stages of development and that the company believes this system "will be superior in performance to other modalities."

The firm will not put much effort into marketing Lorad, Cumming said. Instead, the product line will be phased out as quickly as possible.

"To try to go down two paths with two technologies is not advisable," he said.

Hologic will continue to support the CCD-based Lorad systems in the field, according to Cumming. Four Lorad Digital Breast Imaging mammography systems are currently being used in an ongoing American College of Radiology Imaging Network clinical study, which will enroll 49,500 women in the U.S. and Canada. Other systems are in service in Europe, where the product was cleared for marketing when it still carried the Trex label. Cumming expects that most users of the digital Lorad system eventually will switch to the newer selenium technology.

Cumming would not project when Selenia might be available in the U.S. Hologic has not yet filed a PMA application, he said. Until then, the company's focus will be on Europe and other markets.

"We are going to work closely with the FDA," he said. "We would like to see as expeditious a review as possible. But our focus has to be on Europe and other international markets."

Regulators overseas are less demanding than those in the U.S. (The company has already taken six orders from European customers and expects to begin commercial shipments to international purchasers this summer.) That does not mean, however, that Selenia will be excluded from the U.S. clinical landscape, not even in the short term.

"There will be a fair number of Selenia systems that will be placed at U.S. research sites operating under IRBs (investigational review boards)," Cumming said. "These sites will conduct research that will provide valuable information for clinicians and their patients in the local communities, as well as internationally."