In Brief: Biopsys Medical
This article was originally published in The Gray Sheet
Executive Summary
Biopsys Medical: Firm's Mammotome breast biopsy system gains additional 510(k) clearance clarifying diagnostic indication and contraindicating therapeutic use. The submission was made on Feb. 12 to address FDA's concerns that physicians are using the system for the broader therapeutic application of tissue excision ("The Gray Sheet" Feb. 17, I&W-8). The Irvine, California-based firm received a warning letter from the agency Feb. 5 objecting to promotions the agency believed could be misconstrued as advocating Mammotome's use in breast cancer therapy...