Seno Medical Instruments has received the European CE Mark for its Imagio ultrasound/optoacoustic imaging system.
Imagio fuses optoacoustics with traditional ultrasound. The system produces images that provide a unique blood map in and around suspicious breast masses, which is important as cancerous tumors typically grow new networks of blood vessels, according to the firm.
Imagio provides images of these networks, as well as maps of relative oxygen-rich or oxygen-deprived blood; vascular structures with low oxygen levels are likely to indicate cancer, the company said. Seno Medical hopes the technology can help women avoid unnecessary negative biopsies.
Seno Medical is currently conducting a U.S. study with Imagio that includes 16 hospitals and imaging centers and will form the basis of the company's premarket approval application (PMA) for the U.S. Food and Drug Administration (FDA).