The U.S. Food and Drug Administration (FDA) has approved a mammogram device that will produce 2D and 3D images that will help medical professionals in breast cancer screening and diagnosis.
In a letter addressed to Steven Kachelmeyer, regulatory affairs director of General Electric (GE) Company’s healthcare division, the agency said that its Center for Devices and Radiological Health (CDRH) has completed reviewing the premarket approval application (PMA) for the SenoClaire mammogram device.
“We are pleased to inform you that the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described below,” said [pdf] Janine Morris, director at the Division of Radiological Health of CDRH, in a letter dated Aug. 26.
The sale and distribution of SenoClaire are restricted to prescription use, according to the Code of Federal Regulations (CFR) Title 21, section 801.109 and under the Federal Food, Drug, and Cosmetic Act section 515(d)(1)(B)(ii).
The SenoClaire device is also considered a restricted device following requirements of sections 502(q) and (r) of the same act, apart from other requirements imposed by the FDA.
These restrictions are deemed necessary by the FDA to offer reasonable assurance of the efficiency and safety of the mammogram device, Morris said.
The FDA said the device has software and hardware upgrades to the Senographe Essential 2D, a full-field digital mammography method also approved for conventional mammography.
The software upgrade applies low-dose x-ray images to come up with cross-sectional or tomosynthesis breast views, while the hardware creates multiple low-dose x-ray projection images of breasts.
While producing 2D and 3D images, the mammogram device “can be used for the same clinical applications as traditional mammography for screening mammography.”
According to the FDA, tomosynthesis images will provide further information for physicians in detecting and diagnosing breast cancer.
Morris further reminded GE that continued approval of its PMA for the said mammogram device depends on its submission of periodic reports as required by CFR 21 section 814.84 with intervals of one year unless required otherwise.
The company also must submit a supplement to its PMA or a 30-day notice to the FDA according to CFR 21 section 814.39, before conducting any change to its mammogram device for purposes of safety and efficiency.
GE’s PMA for SenoClaire mammogram device was filed on July 26, 2013 and amended in September and October last year as well as in January and April this year.
