FDA marketing approval! Where does ISGTF go from here??!
Thursday June 26 3:49 PM EDT Company Press Release
ISG's Viewing Wand(R) Receives FDA Clearance for Spine Applications
MISSISSAUGA, ONTARIO--(BUSINESS WIRE)--June 26, 1997--(NASDAQ:ISGTF. -
news) ISG Technologies Inc. (ISG) is pleased to
announce that it has received 510(k) clearance
from the U.S. Food and Drug Administration (FDA)
for spine applications for its image-guided
surgical system, the Viewing Wand.
In 1994, the Viewing Wand was the first system
of its kind to receive FDA clearance. At that
time, it was cleared for use in neurosurgical
procedures in the head and neck. The new
clearance enables ISG to market the system
commercially for use on patients who require
decompressive or reconstructive surgery of the
spine, or who have imaged lesions or
malformations in the spine.
The Viewing Wand is an interactive system used in
the operating room, both in planning and
performing surgical procedures. The system links
advanced imaging software to a position-sensing
device. This allows surgeons to see where key
anatomical structures are located, and plan and
verify their approach and trajectory more effectively. Surgeons report that using the
Viewing Wand results in more precise surgery,
fewer complications, and reduced hospital stays.
Michael M. Greenberg, M.D., Chairman and CEO of
ISG, says: ``This is a significant step in the
evolution of ISG's family of image-guided
surgical systems. For ISG, it means an immediate
increase in our ability to expand our base, and
the opportunity to expand even further in the
future.
For health care enterprises, it means that the
system's significant treatment benefits can be
applied to more than one department, improving
its cost effectiveness. ISG remains committed to
contributing to the enhancement of health care
through the continued development of this and
other leading-edge software applications.''
ISG is the world's leading provider of software
to present, manipulate, analyze, and store
medical images created through CT (computed
tomography), MR (magnetic resonance), and
nuclear scanning devices. ISG's products and
services include: Software Platforms - standard
software tools that accelerate the development
of medical imaging software applications;
Image-Guided Surgery Systems - enabling more
precise and less invasive surgery; Radiology
Application Software - used to collect, report,
and analyze diagnostic information for
radiologists; Contract Engineering -software
development which large medical imaging
companies outsource to ISG; and Services -
technical, application, clinical development,
and marketing services. ISG is a publicly traded
company with over 230 employees worldwide, and
is listed on The Toronto Stock Exchange (ISO)
and on New York's NASDAQ (ISGTF).
The Viewing Wand is a registered trademark of ISG Technologies Inc.
-------------------------
Contact:
ISG Technologies Inc.
Nicole Filiatrault, 905/672-2100 x142
905/672-2307 (FAX)
E-mail: nicole@isgtec.com
isgtec.com |
