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
Mammography 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 tissue,according to Hal Kirshner, president of the Danbury, CT, company.Lorad will also emphasize its ongoing work in both spot and full-field-of-viewdigital mammography.
Lorad has developed a new grid system that works with conventionalfilm/screen mammography units. It produces improved contrast atlow kV levels, especially in dense breast tissue, according toKirshner. Lorad is keeping technical details of the technologyunder wraps, but the vendor will show images acquired with thesystem at this week's meeting.
Lorad plans to offer the new grid as an option on new M-IIIsystems and M-III units in the field, Kirshner said. Clinicaltests are being conducted by Dr. Gillian Newstead at New YorkUniversity Medical Center. Product shipments with the new gridshould begin by early 1996.
In addition to the new grid, Lorad will display improvementsmade to its upright digital spot mammography (DSM) technologyinitially shown at last year's Radiological Society of North Americameeting (SCAN 11/23/94).
The new product, dubbed StereoLoc II, adapts Lorad's DSM deviceto allow digitally guided stereotactic procedures on upright M-IIImammography units. The DSM digital camera now can be used in bothupright and prone biopsy procedures, according to Kirshner. Loradplans to begin shipping StereoLoc II in the next three months.
Lorad's full-field-of-view program is progressing, and in abouta month the company will send the first full-field clinical unitsto sites at the University of Virginia and UCLA Medical Center.These units will be used to gather clinical data to support Lorad'ssubmission to the Food and Drug Administration for regulatoryclearance for full-breast digital.
The FDA indicated earlier this year that it might require mammographyvendors to submit premarket approval applications (PMAs) for full-field-of-viewdigital systems (SCAN 1/18/95). Since then, the agency has relaxedits stance on the issue somewhat, and Kirshner said he has receivedpositive signals from the FDA.
"Although the initial indications were that this wouldbe a PMA filing, there is a chance based on some data that wehave already shown them that this could be put on either a fast-trackPMA or even possibly a 510(k)," Kirshner said. "I don'tget the impression that the FDA is going to hold us up. They aregoing to work with us to speed up the process."