|The somo•v Automated Breast Ultrasound system is designed to detect tumors in women with dense breast tissue--courtesy of U-Systems|
For U-Systems, Sept. 18 has become a hallmark day. The FDA granted premarket approval to use the company's somo•v Automated Breast Ultrasound system to help detect smaller tumors specifically in women with dense breast tissue. Five months ago, a panel of experts recommended regulators do just that.
The product can now be used along with mammography for women who are asymptomatic and have dense breast tissue. Health care gains a first, as well, with this regulatory sign-off. The somo•v system is, for now at least, the only one of its kind approved in the U.S. just to screen women who have dense breasts, which can create added challenges for breast cancer detection. As the FDA explains, dense breasts have much more connective and glandular tissue. And the glandular tissue can obscure smaller tumors, as both can appear as solid white regions on basic mammograms, regulators note. The end result: breast cancer detection can be delayed.
Adding the ultrasound component to the equation should help detect small tumor masses in dense breasts more easily, the FDA and U-Systems both note.
Regulators point out in their announcement that they reviewed, in part, a clinical study where radiologists reviewed mammograms alone or the test along with the somo•v for 200 women who had dense breasts and mammograms that were initially negative. Biopsies showed that the combination diagnostic was much more precise.
And now U-Systems, which is based in Sunnyvale, CA, can add the unique approval indication to sign-offs its already achieved in Canada and 27 European countries. The company pulled in $6.5 million in financing in May, in part, to help it complete its PMA submission and fine-tune its debut product.
- read the company's release
- here's the FDA's announcement