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Spencer Technologies Receives
FDA 510(k) Clearance
New User Friendly Ultrasound Device Better Identifies Conditions Leading to Stroke
SEATTLE, WA - SEPTEMBER 5, 2000
-- Spencer Technologies has received FDA
510(k) clearance to market its new transcranial Doppler (TCD), a noninvasive ultrasound
product for monitoring blood flow in the brain. This product is designed to help diagnose
conditions that may lead to stroke, so that preventative actions may be taken.
The new device is the first digital, stand-alone TCD product to be introduced to the
market. Digitizing the blood flow signals allows Spencer Technologies to incorporate a
unique, patented display, which offers much greater ease of use over current technology,
and has significant technical advantages.
Reactions by physicians and technologists at medical professional meetings this year have
been very enthusiastic. Spencer Technologies has received numerous requests for product
demonstrations from the U.S. and European markets.
According to Spencer Technologies President and CEO Scott Seidel, "With a global base
of approximately 15,000 installed units containing the older analog technology, our
initial sales will likely be driven by customers wanting to replace their existing units
with these newer, more capable machines. However, we expect new users to significantly
expand the TCD market over time as they discover the ease of use and increased capability
of this new product."
Spencer Technologies is dedicated to significantly improving healthcare through
noninvasive technologies for diagnosis, monitoring, and therapy. It is an integrated
patient service, clinical research, R&D, and manufacturing company marketing
innovative products and services through worldwide customer relationships.
In addition, Spencer Technologies sells an ultrasound probe fixation device distributed by
four other TCD companies. Spencer Technologies has four additional products in its
pipeline, all of which are based on the same new digital platform as the TCD now being
brought to market. These products address the detection, prevention, and treatment of
conditions leading to stroke, pulmonary embolism, deafness, and brain hemorrhage. Unique
to the industry, Spencer Technologies utilizes expertise from its clinical patient
business to identify needs for new products and to design these products from a user
standpoint. Spencer Technologies' bioengineers then work closely with clinicians to bring
these innovative products to market.
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