The American College of Radiology (ACR) is now the FDA-approved accrediting body for Hologic's Lorad Selenia full field digital mammography system.
Facilities purchasing the systems can now go directly to the ACR for accreditation. The process initially entailed that facilities file with the FDA for an extension of their existing Mammography Quality Standards Act (MQSA) certification and were also required to have a screen-film system available.
"Since Hologic began commercial shipments of the Selenia system earlier this year, many of our customers have expressed significant interest in developing a filmless breast imaging center," said Hologic Chairman and CEO Jack W. Cumming. "Approval of the ACR as the accrediting agency for the Selenia will enable facilities to proceed with those plans without the expense and effort required to maintain both a screen-film and digital systems."
The FDA has begun contacting facilities that have previously installed Selenia systems to inform them of the new accreditation regiments.