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Device Development
[ Research Design
& Data Analysis ] 
[ Clinical Trials ]
[ Biomedical Engineering ]
ECOM
Monitor Images
The ECOM device is a minimally invasive cardiac
output monitordesigned and tested in the Cardiac Engineering
lab. It has received FDA 510K approval and is beginning to
be marketed by Conmed. http://www.conmed.com/
The ECOM development project required physics,
mechanical engineering, electrical engineering, manufacturing
engineering, software design, time and frequency domain signal
processing, artificial intelligence, adaptive filters, fuzzy
logic, algorithm design, applied math, chronic animal experimentation,
and clinical trial design and execution. We produced more
than 100 chronically instrumented pigs that survived for 30
to 90 days. We designed, manufactured, and tested 33 separate
device designs. We have designed, built, and tested five separate
versions of the measuring electronics each with high speed
computerized data acquisition. We have tested numerous different
algorithm designs. The design and the animal work has been
published in Anesthesiology. We then conducted a 330 patient
multicentered clinical trial in patients undergoing cardiac
surgery. The system have several patents and is FDA 510K approved
for clinical use.
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