FDA clears device to aid in breast localization during imaging-guided biopsy
The U.S. Food and Administration has cleared a new product that aids in breast localization during imaging-guided biopsy, its manufacturer announced Monday.
Merit Medical Systems claims its SCOUT Bx Delivery System is the first wire-free solution providers can deploy during such stereotactic or MRI-based procedures. It allows physicians to place the tiny reflector to precisely target affected breast tissue at the time of the biopsy, rather than requiring an additional appointment.
“Patients appreciate that they do not have to return to the breast center for a second procedure at a stressful time in their treatment planning,” Brett T. Parkinson, MD, a diagnostic radiologist with Intermountain Healthcare in Salt Lake City, Utah, and Merit Medical consultant said in a statement.
More than 300,000 women undergo breast cancer surgery in the U.S. annually, Merit noted, and providers perform 40% of biopsies under MRI or stereotactic guidance. The South Jordan, Utah-based vendor claims the system can help to streamline the care pathway for these patients, allowing providers to perform more procedures while opening access. Its SCOUT system has now aided in almost 300,000 breast localizations across the globe, experts estimated.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.