DMS (Direct Medical Systems) seeks US nod for mammography system
This article was originally published in Clinica
Executive Summary
Direct Medical Systems (DMS) has filed with the FDA its M3000 mammography system for US marketing clearance. Upon FDA-approval, which the company expects to receive in early 2006, DMS said it would distribute the product through "one of the largest distributors and service organisations in the US". Details of the agreement are expected to be announced at the end of 2005, the San Ramon, California firm told Clinica. The company added it was also seeking to gain US marketing clearances for its 8-slice computed tomography (CT) system and 0.3T and 0.4T MRI systems. Marketing applications are expected to be submitted to the FDA "over the next few months".