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
It's a long way from Star Wars to the war on breast cancer, butnot too far for mammography vendor Fischer Imaging. The Denvercompany this month signed an agreement with the Department ofEnergy to develop a full-field-of-view digital mammography unit.The
Fischer Imaging is hot on the heels of competitor Lorad in therace to develop a full-breast digital mammography system. Denver-basedFischer plans to display a full-view digital system as a works-in-progressat the Radiological Society of North America
A technological jump-start from its parent company has aided Lorad'squest to develop a digital mammography system capable of full-viewbreast imaging. Lorad plans to show images from a prototype systemat this year's Radiological Society of North America
