Merit Medical Receives FDA Clearance for its Scout Bx Breast Biopsy System

Merit Medical Systems has received the FDA’s 510(k) clearance for its Scout Bx system, which delivers a wire-free reflector that can be implanted during biopsies to aid in follow-up surgeries.

Cleared for long-term implantation, the Scout Bx system is compatible with the most commonly used stereotactic and MRI-guided breast biopsy devices, the South Jordan, Utah-based company said.

“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,” said Brett Parkinson, a diagnostic radiologist at Intermountain Healthcare in Salt Lake City who is a consultant for Merit.