Mammography

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

Fischer Imaging has jumped ahead of competitors Bennett X-Rayand Lorad Medical Systems in the digital mammography race (SCAN2/12/92). The three companies are working on charge-coupled device(CCD) x-ray systems for mammographic applications. Fuji

Although mammography's resolution requirements have kept thatmodality bound to film, efforts are under way to bridge the digitalgap. Both Bennett X-ray and Lorad displayed works-in-progressdigital mammography technology at the 1991 RSNA exhibition.