News: FDA Grants Stratasys Marketing Clearance for MedModeler Device
Creates 3D Plastic Anatomical Models from CT/MRI Data
MINNEAPOLIS--(BUSINESS WIRE)--Dec. 1, 1997-- Stratasys announced that their MedModeler device has been granted 510(k) premarket clearance by the FDA.
The Stratasys FDM MedModeler is indicated as an image processing accessory, used to create three dimensional models from 3D surface representation data or 2D contour data. It can be used as a diagnostic tool, a pre-operative planning tool, or to enhance communication with patients or other professionals.
Lisa Crump, Stratasys vice president/business development, stated, ''We are excited to enter the promising medical market with the Stratasys MedModeler, which is the first rapid modeling system to be cleared by the FDA for use in the hospital setting. We are able to support the needs of the surgeon and radiologist by providing a modeling system that can create patient-specific models. A physician can gain additional information for making a diagnosis by examining a three dimensional model. The surgical team can utilize the model to formulate or rehearse operating techniques in advance of surgery or as an aid in communication.''
The Stratasys MedModeler is based on the thermal FDM (Fused Deposition Modeling) patented technology. The user has the choice to create models out of medical grade ABS (methyl methacrylate/acrylonitrile/butadiene/styrene) or ABS, both durable, non-toxic plastic materials. When used in conjunction with CT/MRI data, overall tolerance is +/- .030 inch. Build area is up to 10 x 10 x 10 inches and is compatible with Windows NT and UNIX systems. System can be used in an office/hospital environment. MedModeler interfaces with qualified CT/MRI converter software packages.
Stratsys Inc., founded in 1989, is a manufacturer of rapid prototyping devices for the automotive, aerospace, industrial, electronic, medical and consumer industries. The company's patented Fused Deposition Modeling (FDM) and Genisys rapid prototyping processes create 3-dimensional plastic and wax prototype parts directly from 3-D CAD systems. See the company's home page, www.stratasys.com on the Internet. The company is located at 14950 Martin Drive, Eden Prairie, Minnesota 55344-2020. Please visit the Stratasys web site at stratasys.com .
Except for the historical information contained herein, the matters discussed in this news release are forward looking statements that involve risks and uncertainties, including the timely development and acceptance of new products, the impact of competitive products and pricing, and the other risks detailed from time to time in the company's SEC reports, including the report on Form 10-Q for Q3-97 and Form 10-K for the year ended Dec. 31, 1996. |
