FDA clears first 2D mammography device with patient-controlled compression

 

The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.

Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.

The mammography system was cleared through the FDA’s 510(k) process after the agency determined that it was at least as safe and effective as Senographe Pristina, which is already on the market. A clinical validation showed that the addition of the self-compression remote did not negatively impact image quality or significantly increase exam time.

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”

Read more details of the clearance on the FDA’s website.

llaubach@frontlinemedcom.com

 

The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.

Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.

The mammography system was cleared through the FDA’s 510(k) process after the agency determined that it was at least as safe and effective as Senographe Pristina, which is already on the market. A clinical validation showed that the addition of the self-compression remote did not negatively impact image quality or significantly increase exam time.

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”

Read more details of the clearance on the FDA’s website.

llaubach@frontlinemedcom.com

 

The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.

Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.

The mammography system was cleared through the FDA’s 510(k) process after the agency determined that it was at least as safe and effective as Senographe Pristina, which is already on the market. A clinical validation showed that the addition of the self-compression remote did not negatively impact image quality or significantly increase exam time.

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”

Read more details of the clearance on the FDA’s website.

llaubach@frontlinemedcom.com