Mammography

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

The full-field digital mammography landscape shifted with breathtaking speed last month when the Food and Drug Administration’s Radiological Devices Panel of the Medical Devices Advisory Committee unanimously recommended clearance for GE Medical

Digital mammography developers received a surprise at the RSNA show this year when GE announced that it had filed a premarket approval application (PMA) in October for its unit, Senographe 2000D. The news changed the digital mammography landscape

Senographe 2000D wins expedited review In September, the Food and Drug Administration sparked controversy with its suggestion that full-field digital mammography vendors submit a premarket approval application (PMA) for their devices, rather than

PMAs will require post-approval screening trial With its latest communication on the regulatory process for full-field digital mammography to some vendors last month, the Food and Drug Administration’s Center for Devices and Radiological

FDA offers regulatory alternative to digital mammography vendorsCDRH proposes PMA for clearanceSome full-field digital mammography developers received a shock this month when the Food and Drug Administration’s Center for Devices and

Agency claims full-scale study needed for 510(k)Some full-field digital mammography developers received a shock this month when the Food and Drug Administration’s Center for Devices and Radiological Health articulated its latest position on

GE Medical Systems has made its first commercial installation of Senographe 2000D, the company’s full-field digital mammography system. The unit received the CE Mark for European regulatory clearance this spring (SCAN 3/17/99), and on Sept. 2

TDMS application no longer under review by agencyTrex Medical’s commitment to digital mammography in the U.S. has been tested yet again. This month the Danbury, CT, company received more bad news about its Trex Digital Mammography System

Company joins Trex Medical as only firms with approvalGE Medical Systems has begun European shipments of its Senographe 2000D full-field digital mammography system, the company announced at last week’s European Congress of Radiology in