FDA clears Artemis' image-guided breast biopsy device:
This article was originally published in Clinica
Executive Summary
Artemis Medical has received US FDA 510(k) clearance for its MiniTome breast biopsy system. The device can localise and immobilise target breast tissue more precisely than current techniques, Artemis claims. It can also accurately cut and remove a large, architecturally intact sample through a minimally invasive incision. An intact sample provides a more definitive diagnosis, explains the Hayward, California firm. Around 1.4 million breast biopsies are performed in the US annually, over 50% of which use open surgical techniques in order to acquire a large intact sample, notes the company.