The likelihood of FDA approval for U-Systems' somo•v Automated Breast Ultrasound system just got better this week. That's because an advisory panel of experts recommended regulators sign off on the company's PMA application for the equipment, which is targeted to a breast cancer screening indication.
Right now, the system is cleared for use as a diagnostic tool along with a mammography.
FDA officials don't have to follow the recommendation from its radiological devices panel of the Medical Devices Advisory Committee. But approval or rejection of a device or drug typically follows the route of an advisory panel vote. With an expanded indication, the company says the system would be the only ultrasound device of its kind approved for breast cancer screening, along with mammography, for women with dense breast tissue who aren't displaying any symptoms.
As many as 35% of breast cancer cases aren't detected by mammography in women with dense breasts, because the density masks the tumors, according to a New England Journal of Medicine study cited by the company. That number gives U-Systems an opportunity to market its somo•v system as something unique that fills a current care void.
"If the FDA approves the somo•v PMA, this important adjunctive screening tool for women with dense breasts has the opportunity to become widely available in clinical practice," U-Systems President and CEO Ron Ho said in a statement.
The Sunnyvale, CA-based company raised $6.5 million in May to help it finish a crucial clinical trial, fine-tune its debut product and complete its PMA submission.
- here's the release