Mammography

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

Company faces lower 1999 earnings after U.S. Surgical deal diesThe weeks in December between the Radiological Society of North America meeting and the New Year are usually times for medical imaging companies to relax. Not so for Trex Medical last

Despite continued disappointment at the Food and Drug Administration’s reluctance to clear full-field digital mammography systems, vendors at the RSNA conference were optimistic about the development of digital and other emerging technologies. In

Firm seeks low-cost solution for large-format imagingAs full-field digital mammography vendors continue their slow progress toward Food and Drug Administration clearance, a new company has appeared on the horizon with a unique approach to digital

TDMS clearance is first for a full-field digital mammography deviceOnce again, Europeans will be the first to gain access to cutting-edge technology developed in the U.S. for digital mammography. This time, the technology involved is a full-field

New rules could affect regulatory submissions of full-field systemsThe Food and Drug Administration plans to revise its 1996 guidelines governing 510(k) submissions for full-field digital mammography systems, the agency has said. Digital