Mammography

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

Company has big plans in digital mammographySchick Technologies has some grand ambitions, and potentially the technology to achieve them. The six-year-old company, headquartered in Long Island City, NY, is using digital x-ray technology, developed

This Finnish company (Hall B, #7142) is developing a full-field digital mammography system that it plans to offer as a retrofit to its installed base of Sophie screening units. Sophie Digital uses charge-coupled device (CCD) technology and a

Instrumentarium Imaging (Hall B, #8303) has kept a lower profile than some of its mammography competitors regarding the development of digital mammography technology, but that will begin to change at this year's meeting. The Milwaukee company will

X-ray vendor Trex Medical (Hall A, #3500) has completed the clinical trials required for a regulatory submission of its full-field digital mammography detector and is planning to submit a 510(k) filing for the product some time around the RSNA show,

DICOM committee votes to keep compression group aliveDigital mammography group also formedThe DICOM standards committee voted at its August meeting to keep active its working group charged with developing standards to cover new lossy

Vendor hopes to leapfrog CCD-based detectorsGE Medical Systems in March found an influential audience with whom to discuss its ongoing work on full-field digital mammography. The Milwaukee vendor presented the progress of its full-field R&D to

Nuclear Associates of Carle Place, NY, has begun marketing a digitalmammography phantom that makes it easier to compare the imagequality of digital and conventional mammography biopsy systems.Due to the phantom's small size (6.7 x 6.4 cm, with a 4-cm

A California start-up called PrimeX General Imaging (PGI) has won a $1.6 million grant from the U.S. Army to build a prototype next-generation full-view digital mammography device. If technological hurdles are overcome, the PGI device could be the

Like competitors Bennett X-Ray and Lorad, Fischer of Denver isdeveloping a full-view digital mammography system. In its RSNAbooth, the company for the first time will display a working prototypeof its full-view digital system and will show patient images

Lorad of Danbury, CT, will show its latest developments in bothscreen-film and digital mammography in its RSNA booth. On theconventional side, Lorad will introduce M-IV, its newest mammographyplatform and successor to M-III (SCAN 10/11/95). M-IV's high

The Food and Drug Administration has released a draft versionof rules intended to guide manufacturers through the regulatoryreview process for full-view digital mammography devices (SCAN9/13/95). The guidelines cover several areas, including a

Agency still undecided on 510(k) vs. PMA issueThe Food and Drug Administration is attempting to clarify theregulatory status of full-view digital mammography by releasinga draft protocol that it expects vendors to use to receive clearancefor

Vendor also displays advances in digital mammographyMammography vendor Lorad will introduce a new grid technologyat this week's Society of Breast Imaging meeting in Orlando thatimproves contrast and resolution in images of dense breast

The Food and Drug Administration's radiological devices panel of the medical devices advisory committeewill be meeting on March 6 to discuss requirements for submissionsof digital mammography device approval applications. The meetingwill cover the FDA's

FDA to regulate full-FOV systems as class-three devicesThe much anticipated market introduction of full-field-of-viewdigital mammography systems for screening and diagnosis couldbe postponed for years as a result of a Food and Drug

Firm targets 1995 for commercial releaseThe rapid growth of digital mammography is spurring the developmentof computer-aided diagnosis (CAD) products to help mammographerslocate and analyze suspicious areas on mammograms. At this

Bennett X-Ray has trailedFischer and Lorad in commercializing a digital spot mammographyproduct, but the Copiague, NY, firm plans to leapfrog the competitionat next week's meeting. Bennett has made strides growing its digitaltechnology thanks to a

Anyone who doubted the future of digital mammography must be thinkingtwice after this year's Radiological Society of North Americameeting. Digital systems were featured prominently on the exhibitfloor. Fischer Imaging and Lorad displayed