Seno Medical Instruments Inc. has received the CE Mark for its Imagio opto-acoustic imaging system, which could give the San Antonio, Texas-based device company market penetration for its medical device in Europe.
The Imagio technology is designed to improve the process of diagnosing breast cancer, eliminating the need for intrusive biopsies for some patients.
Seno currently is engaged in a pivotal study to determine the effectiveness of its technology.
“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,”Seno CEO Janet Campbell said about the company’s Imagio technology. “The CE Mark means we can now commercialize this new breast imaging system in Europe, and it gives us the opportunity to continue developing our relationships with physicians and regulators in the EU.”
Each year, millions of women around the world undergo core needle or surgical breast biopsies after a suspicious mass is found through breast imaging or self-exams. Seno officials say studies show that more than 80 percent of these biopsies reveal benign pathology after they are analyzed in a laboratory.
The Imagio Pivotal Study is ongoing in the United States. It involves 16 hospitals and imaging centers throughout the country. The study will form the basis of the company’s pre-market approval application to seek approval from the U.S. Food and Drug Administration for its technology.