U-Systems has announced it has received an FDA premarket approval letter for its somo*v Automated Breast Ultrasound system, according to a news release.
U-Systems said the somo*v ABUS system is the first ultrasound device to receive an approval recommendation from a FDA advisory panel and an approval letter for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.
"The breast imaging community has known for some time that mammography does not work equally well in everyone, particularly the 40 percent of women in the United States who have dense breast tissue," said Ron Ho, president and CEO of U-Systems, in the release. "We are very excited to receive a PMA approvable letter for a breast cancer screening indication for the somo*v ABUS system, and to be one step closer to offering radiologists an important adjunctive screening tool which has the potential to find some 30 percent additional cancers that would not have been found with mammography. We are pleased that our development efforts, now supported by the FDA's scientific review of our safety and clinical data, are bringing us close to final PMA approval. With this response from the FDA, we will begin preparing for the launch of the somo*v ABUS system across the United States."
Final approval of the PMA application remains subject to satisfactory review and inspection of U-Systems manufacturing facilities, methods and controls.
U-Systems is headquartered in Sunnyvale, Calif.
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