US-based Seno Medical Instruments has received the CE Mark for Imagio, a new opto-acoustic imaging system, in Europe.
Seno is in the middle of its pivotal study whose purpose is to determine if this technology will provide new information to the physician to decide if a woman may avoid negative (unnecessary) biopsies.
Seno CEO Janet Campbell noted that experts recently presented data from the Imagio feasibility study at the European Congress of Radiology in Vienna, and it was enthusiastically received by European key opinion leaders.
"The CE Mark means we can now commercialize this important new breast imaging system in Europe and gives us the opportunity to continue developing our relationships with physicians and regulators in the EU," Campbell added.
Seno’s Imagio fuses opto-acoustics, a technology based on ‘light-in and sound-out’, with traditional ultrasound. The opto-acoustic images provide a unique blood map in and around suspicious breast masses. Cancerous tumors grow relatively quickly and require significant amounts of blood and oxygen, so a network of blood vessels grows around cancerous masses.
Imagio provides images of these networks and a map of relative oxygen-rich or oxygen-deprived blood. Radiologists believe that Imagio images depicting significant vascular structures and low oxygen levels are likely to indicate cancers.
Unlike other functional fusion technologies, Imagio uses no x-rays (ionizing radiation) or injectable contrast agents to obtain its information, thereby reducing the patient’s exposure to any potentially harmful aspects of imaging.
The Imagio pivotal study is ongoing in the US and includes 16 leading hospitals and imaging centers throughout the country. The study will form the basis of the company’s pre-market approval application (PMA) to seek US approval from the US Food and Drug Administration.