The U.S. Food and Drug Administration (FDA) has approved the American College of Radiology (ACR) to accredit Siemens Healthcare's Mammomat Inspiration full-field digital mammography (FFDM) unit.
The ACR will begin contacting facilities that already use the vendor's Inspiration systems under an FDA-approved extended Mammography Quality Standards Act (MQSA) certificate to advise them of the change and how to proceed with accreditation. These facilities do not need to take any action toward accreditation until they are contacted by the ACR, and they are permitted to operate during the transition period, according to the FDA.
The FDA said it will no longer accept applications to extend existing MQSA certificates to include the use of Inspiration systems.
