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Spencer Technologies Files for FDA
Clearance
New User Friendly Ultrasound Device Better Identifies Conditions Leading to Stroke
SEATTLE, WA - JULY 12, 2000 -- Spencer Technologies has filed a 510(k)
submission with the FDA for clearance to distribute 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 product design to be introduced to the TCD 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.
Initial reactions by physicians and technologists at medical professional meetings this
year have been very encouraging. Spencer Technologies has received a number of requests
for demonstrations after the device is released for sale.
According to Spencer Technologies President and CEO Scott Seidel, "With the existence
of an installed global base of approximately 15,000 units containing the older analog
technology, we think initial sales will likely be driven by customers wanting to replace
their existing units with newer, more capable technology. However, during this time of
unprecedented interest in stroke prevention by the medical community and the public, the
introduction of this much more user friendly and technologically advanced product will
encourage many new users to jump in and significantly expand the TCD market over
time."
Seidel also announced a recently completed first round financing from private
"angel" investors.
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.
Spencer Technologies currently sells an ultrasound probe fixation device, which is
distributed by four TCD companies. Spencer Technologies is developing five proprietary
Doppler ultrasound products addressing 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 with clinicians to bring these
innovative products to market. Incorporated in the State of Washington in 1992, Spencer
Technologies is located at 701 16th Avenue, Seattle, WA 98122. |
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