The U.S. Food and Drug Administration (FDA) announced on Tuesday that it has approved a full-field digital mammography (FFDM) unit from Swedish mammography and PACS developer Sectra. The approval is the latest since the agency revised its rules in November 2010 on new FFDM approvals.
The FDA said that on April 28 it issued 510(k) approval for the Sectra MicroDose Mammography L30 system, giving the vendor the go-ahead to sell the system in the U.S. The approval is the fourth since the November revision.
In its November 4, 2010, announcement, the FDA said it was reclassifying FFDM systems from high-risk class III devices to medium-risk class II devices. The change meant that new digital mammography systems would no longer be required to navigate the premarket approval (PMA) process, which requires clinical trials, and instead could use the less cumbersome 510(k) process, which simply requires that vendors demonstrate that their products are "substantially equivalent" to previously approved devices.
Since November, the agency has approved four FFDM products:
- The Sectra MicroDose L30 unit, approved last week.
- The Selenia Dimensions digital breast tomosynthesis (DBT) system from Hologic, approved on February 11, 2011.
- The Mammomat Inspiration FFDM system from Siemens Healthcare, approved on November 5, 2010.
- The DirectView computed radiography (CR) digital mammography system from Carestream Health, approved on November 3, 2010.
Prior to that, the FDA had not approved an FFDM system since Hologic's Selenia Dimensions FFDM unit, in February 2009.
Other companies that may also soon introduce FFDM systems in the U.S. include Philips Healthcare, Agfa HealthCare, Planmed, Fujifilm Medical Systems USA, and IMS.
