US FDA Clears the First 2D Digital Mammography System with Optional Patient-Assisted Compression

On September 1, 2017, the United States Food and Drug Administration (US FDA) cleared the first 2D digital mammography system that enables patients to adjust the amount of compression applied to the breast during mammography.

A regular mammogram is an effective imaging tool in early detection of breast cancer, but some patients feel discomfort and pain due to compression applied during the procedure.However, this new device allows patients some control over the amount of compression, hence making the experience more comfortable.

Mammography System:

Conventional mammogram utilizes a low-dose X-ray system to take the 2D picture of breasts on an X-ray film.Digital mammography is a 2D mammography system in which the X-rays are captured on a specially designed digital detector that converts the X-rays into electronic signals, which are then transferred to a computer for review by the radiologist.Breast tomosynthesis also called as 3D mammography or Digital breast tomosynthesis (DBT) is an advanced form of digital mammography where multiple images of the breast from different angles are captured and reconstructed into a three-dimensional image set using specific algorithms. This technique has a specific advantage of the improved visibility of breast tissue thus reducing or eliminating tissue overlap.

Senographe Pristina (Newly Approved Mammography System):

The Senographe Pristina with self-compression, developed by GE Healthcare, is a digital mammography system which empowers the patients to reach the compression that is right for them thus reducing the anxiety and making them more comfortable during the imaging. The system includes a wireless remote control held by the patient to adjust the force of compression applied to the breasts. The technologist positions the patient and the patient is asked to use the remote control to gradually increase the level of compression to a point that is tolerable. The technician then checks and verifies whether the compression is adequate to achieve a clear image or needs to be adjusted.

The device makes the Senographe Pristina the first 2D digital mammography system to offer patient-assisted compression in addition to other added features for increased comfort for the patient during exams, such as the design of the system, which consists of rounded soft curved surface and armrests to increase the relaxation for patients.

Pre-Market Clearance by US FDA:

The Senographe Pristina with self-compression was reviewed through the premarket notification 510(k) pathway. A 510(k) is a premarket submission made to the US FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent to a legally marketed device that is not subject to premarket approval. A clinical validation demonstrated that allowing patients to control compression via the remote control did not worsen image quality compared with the predicate device. Additionally, it also did not show any significant increase in the average time taken to perform the mammogram as compared to the examination performed solely by the technician. The US FDA determined that the Senographe Pristina with self-compression is substantially equivalent to the predicate device Senographe Pristina, and thus granted the premarket clearance of the Senographe Pristina with self-compression to GE Healthcare.

Scope in India and Worldwide:

As per the latest data reports from various cancer registries, breast cancer is found to be the most common cancer among females in India and worldwide. During 2016, approximately 1.5 lacs new cases of breast cancer were registered which were over 10 percent of all cancers. The major reason for breast cancer mortality is a diagnosis at an advanced stage of the disease. Regular breast screening is the best way to detect early breast cancer. The primary health care providers should make the general population aware of the breast cancer screening procedures including the benefits of mammographic screening. Several studies on breast cancer screening found that anxiety, pain, and discomfort during the examination influence the patient’s perception for mammography thus avoiding having future screening. The sense of control, along with reduced pain and discomfort, could significantly change the patient’s perception of mammography and their decision to undergo the screening procedure. Thus, it can be forecasted that approval of diagnostic techniques that are more convenient to patients will help in early diagnosis of breast cancer and thus in the effective management of the deadly disease.


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