Digital Mammography Approval Times Accelerate; Adoption May Take Longer
This article was originally published in The Gray Sheet
Executive Summary
Swift FDA approval of PMAs for full-field digital mammography systems, such as Hologic's LORAD, is anticipated following rapid turnaround of the Fischer SenoScan system approval.
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Hologic's LORAD
Full-field digital mammography system gains FDA "approvable" status, with final approval subject to agreement on final labeling, criteria on use of the product and completion of a good manufacturing practices audit. While the first-generation system is based on charge-coupled device (CCD) technology, a second-generation system using amorphous selenium DirectRay direct-to-digital technology is under development, and a PMA supplement filing is anticipated in the first quarter of 2002 (1"The Gray Sheet" Oct. 8, 2001, p. 28)
Hologic's LORAD
Full-field digital mammography system gains FDA "approvable" status, with final approval subject to agreement on final labeling, criteria on use of the product and completion of a good manufacturing practices audit. While the first-generation system is based on charge-coupled device (CCD) technology, a second-generation system using amorphous selenium DirectRay direct-to-digital technology is under development, and a PMA supplement filing is anticipated in the first quarter of 2002 (1"The Gray Sheet" Oct. 8, 2001, p. 28)
Mammography Device Review Warrants More Statisticians On Panel - IoM
FDA's Radiological Devices Panel should include more experts in biostatistics, technology assessment and epidemiology to ensure an appropriate regulatory path for innovative breast cancer diagnostics and to eliminate the regulatory uncertainties faced by digital mammography manufacturers, the Institute of Medicine recommends in a report released March 8.