> (STRATASYS)(SSYS) FDA Grants Stratasys Marketing Clearance for MedModeler
> Device
>
> MINNEAPOLIS--(BUSINESS WIRE)--Dec. 1, 1997--
>
> Creates 3D Plastic Anatomical Models from CT/MRI Data
>
> 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.
>
> [ . . . ]
> See the company's home page at http://www.stratasys.com
------------------------
Yakov Horenstein
Milano, Italy
attached mail follows:
(STRATASYS)(SSYS) FDA Grants Stratasys Marketing Clearance for MedModeler
Device
(Business Wire; 12/01/97)
Business/Technology Editors
MINNEAPOLIS--(BUSINESS WIRE)--Dec. 1, 1997--
Creates 3D Plastic Anatomical Models from CT/MRI Data
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 http://www.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.
--30--kdb/ny*
CONTACT: Stratasys, Inc.
Scott Crump, 612/937-3000
or
Sunrise Financial
Derek Caldwell, 212/421-1616
KEYWORD: MINNESOTA
INDUSTRY KEYWORD: COMPUTERS/ELECTRONICS COMED PRODUCT
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