Mammography

The FDA issued Hologic an approvable letter in mid-July for its Lorad Selenia digital mammography system. The full-field product is based on an amorphous selenium detector plate developed by Direct Radiography, which Hologic purchased three years ago.

FOV and instant imaging minimize errorsMammography depends as much on operator skill as technology. Poor positioning directly affects image quality, reducing the chance for breast cancer detection and accurate staging. Certain

Detector for digital mammography delayedTrixell is ramping up production of its Pixium 4800, a dedicated digital detector for cardiac catheterization. Philips Medical Systems is already building the detector into its Integris

Full-field digital mammography (FFDM) has a slight edge over conventional screen-film systems when characterizing microcalcifications, according to German researchers. FFDM came out on top when compared to screen-film mammograms of patients with

Computer-aided detection software developed by R2 Technology can now be marketed as an integral part of the GE Senographe 2000D full-field digital mammography system, following FDA approval. This is the latest step in R2's pioneering efforts to make CAD

Hologic hopes to enter a strategic alliance with Agfa to help develop its amorphous selenium digital mammography system. The collaboration, which could be finalized in the next several months, would leverage Agfa's strength in image processing

Hologic exec declares new product DOAJust 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

A powerful national computing grid designed to advance breast cancer screening and diagnosis has been established by the University of Pennsylvania. The National Scalable Cluster Project supplements the National Digital Mammography Archive ( see

The wait for the digital mammography market to take shape may finally be over. Fischer Imaging has joined GE in selling full-field digital units in the U.S., and Hologic, with an

FDA ‘approvable letter’ sets stage for launchHologic is running the last lap of a marathon effort to bring its Lorad full-field digital mammography system to market. The company has received an approvable letter from

Amorphous selenium detector will follow CRSiemens Medical Solutions is preparing to get into full-field digital mammography—but not like its competitors. Most competitors, including companies whose equipment is at or near

Customers shopping for full-field digital mammography systems have another product to consider. The FDA has cleared Fischer Imaging’s SenoScan for sale in the U.S. In making the announcement Sept. 25, Fischer executives predicted that a large

For years, proponents of digital mammography have focused on the inherent cost-effectiveness of digital mammography. But that may not be its best selling point. Increased efficiency and its effect on patient throughput could be the keys that open the

Business is booming for the maker of specialty digital mammography and x-ray imaging systems. In its second quarter, end July 1, the company reported revenue up $900,000 to $12.8 million compared with $11.9 million for the same quarter last year. Net

Full-field digital mammography is receiving a full-court press by imaging vendors, several of which are in various stages of device testing or FDA review. But regulatory approval is only the first hurdle. More serious is the challenge to show a clearcut

Just four months after filing a premarket approval application with the FDA, Fischer Imaging has received an approvable letter for its SenoScan full-field digital mammography system.Once final approval is received—Fischer executives hope as early

Specificity has long been the weak spot of computer-aided detection. Pattern-matching algorithms have traditionally marked everything suspicious, leading radiologists to complain that CAD systems did little more than redirect them to do a second read.CAD

The FDA has warned GE Medical Systems that certain procedures surrounding the manufacture, packaging, and shipping of GE’s digital mammography system are not adequate. The allegations, made in an April 10 warning letter, followed a routine

Designers of a project called the National Digital Mammography Archive are assembling a prototype national database comprising thousands of digital mammograms. Their goal is to assist and improve breast cancer detection and diagnosis. The NDMA, a

While full-breast digital mammography continues to garner attention in medical meetings and technical conversations, screen-film mammography remains the industry's bread and butter technology-at least for the moment. Although digital technology has

Eastman Kodak is moving aggressively into digital imaging with two new systems developed with Hologic and plans to market a full-field digital mammography system in the near future.Both systems have amorphous selenium detectors developed by Hologic's

Proposals in Congress to increase payments for digital mammography procedures have led to a split between the American College of Radiology on one side and vendors and an advocacy group on the other.With Congress poised to adjourn this week, the

Responding in part to concerns that screening mammography exposes women to unnecessary radiation, Sweden-based Sectra has developed a work-in-progress digital system that it claims can reduce x-ray exposure by up to 80%.The system, which has not been

Trex Medical has hired Dr. Joel Gray as vice president of business and clinical development. Gray was hired for his imaging expertise as the company prepares for premarket approval of its full-field digital mammography system this year, said

Mainstream medicine ready for computer-aided diagnosis First products likely in cardiology and cancer Computer-aided diagnostics—the use of software-based data analysis to enhance clinical diagnoses, often at the point of

Dr. Lim Cheung has joined DOBI Medical Systems to advance the company's Dynamic Optical Breast Imaging system after spending six years at Trex Medical, where he developed that company's digital mammography unit.Cheung took over last month as the New

Fischer Imaging's revenue is down as it prepares an FDA submission for its SenoScan full-field digital mammography system.Revenue decreased 3% to $13.7 for the first quarter of 2000 (end April 2) compared to $14.2 million for the first quarter of

Although GE Medical Systems was the only company at the American College of Radiology’s National Conference on Breast Cancer this month that sells digital mammography units in the U.S., other exhibitors showing their systems have already asked for

With Food and Drug Administration approval for a full-field digital mammography system finally arriving this year, the new imaging technique will be a hot topic at the American College of Radiology’s 29th conference on breast cancer in San

Industry predictions proved correct last month when GE Medical Systems received premarket approval from the Food and Drug Administration for its full-field digital mammography unit, Senographe 2000D. The news made GE the first company to win the right to