FDA clears GE's patient-assisted compression mammo unit

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The U.S. Food and Drug Administration (FDA) has cleared GE Healthcare's Senographe Pristina with Self-Compression system, a 2D digital mammography unit that allows patients to adjust the amount of compression applied to their own breast before the mammogram is taken.

Senographe Pristina with Self-Compression features a handheld wireless remote control that patients use to adjust the compression force after breast positioning, the FDA said. During a mammography exam, the technologist positions the patient, begins compression, and then guides the patient to gradually increase pressure until adequate compression is reached.

The device was reviewed via the 510(k) process, according to the FDA. The agency determined that the system is "substantially equivalent" to GE's Senographe Pristina and that "the addition of a remote to allow self-compression did not negatively impact image quality," it said.

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