superDimension Receives FDA Approval on Lung Monitoring Tool Designed with PLM Solutions from IBM and Dassault Systèmes
superDimension cuts development time of innovative lung cancer diagnostic device by 30% using SMARTEAM
Paris, France – November 15, 2004– IBM and Dassault Systèmes (Nasdaq: DASTY; Euronext Paris: #13065, DSY.PA) today announced that superDimension Ltd., a medical equipment manufacturer that specializes in minimally invasive diagnosis and treatment of lung disease via CT-guided bronchoscopy, has developed and received US Food & Drug Administration (FDA) approval of its superDimension™/Bronchus system using their Product Lifecycle Management (PLM) technology.
IBM PLM Solutions, with SMARTEAM for collaborative product data and lifecycle management developed by Dassault Systèmes, have enabled superDimension to develop and deliver a real-time minimally invasive lung navigation system an estimated 30% faster than originally planned. The innovative medical device, the superDimension/Bronchus system, improves the success rate in diagnosing and treating lung cancer and other lung diseases via CT-guided bronchoscopy by enabling access to the peripheral areas of the lungs in a minimally invasive manner.
superDimension used SMARTEAM’s regulatory approval template to speed superDimension/Bronchus through regulatory approvals, in this case, the U.S. government’s Food and Drug Administration (FDA) certified Code of Federal Regulations (CFR) 21 Part 11. The template feature stores thousands of pages of superDimension’s design reviews, market data and engineering data in an easily searchable, organized, secure, and audited structured platform with electronic signatures for accountability.
“Using SMARTEAM, the cycle time at superDimension for developing superDimension/Bronchus was reduced dramatically, and we expect even more time-savings once we start production and begin outsourcing components,” said David Tolkowsky, president and CEO of superDimension. “PLM technology has helped us develop a tool that was affordable and could be delivered very rapidly.”
“In addition to data management, SMARTEAM was also used to create a complex workflow for engineering change orders and change requests in the development of the Bronchus System,” said Denis Senpéré, vice president PLM Europe, Dassault Systèmes. ”Using SMARTEAM for the entire process, changes are quicker, more accurate, paperless, and can easily be updated and accessed online.”
superDimension/Bronchus has also received the CE Mark approval, which indicates that a product complies with the essential requirements of European laws, and has successfully completed clinical trials in Germany and Israel.