FDA CLEARS MDX'S NEW PACS SYSTEM

Medical Diagnostic Exchange (MDX) has received FDA clearance for U.S. marketing and sale of the Insight PACS/RIS (Picture Archiving and Communication System/Radiology Information System).

The Insight PACS/RIS system includes wireless or mobile handheld devices that function as full-featured clinical workstations -- with access to all image data at full resolution and access to all necessary tools, even for volume reconstructions and 3D analysis. The clearance covers the complete Insight system, including: the system architecture; the deployment of wireless and mobile handheld devices as clinical review workstations (PDAs and SmartPhones); the distribution technology (streaming); and a number of clinical application modules.

The system also employs the Virtualized PACS Services (VPS) integration engine. Via the VPS, sites that already have digital PACS systems can employ the Insight system to easily distribute access to the existing data throughout the enterprise, the company said.