FDA says Florida imaging center can perform mammography services again after improvements

The FDA announced this week that Lakes Radiology II in Sunrise, Florida, has had its accreditation reinstated and was issued a Mammography Quality Standards Act certificate. The facility, which had its mammography services put on hold by the agency earlier this year due to “serious deficiencies with clinical image quality,” is now performing mammograms once again.

Back in February, the American College of Radiology (ACR) reviewed work performed by the center, determining that its mammograms did not meet ACR standards. After those issues were found, the FDA required Lakes Radiology II to perform a Patient and Referring Healthcare Provider Notification (PPN) to tell at-risk patients and their healthcare providers that quality at the facility was not up to par.

Now, with the PPN completed and all other necessary changes made, the center can get back to screening patients.