CHAD Therapeutics receives FDA clearance for sleep diagnostic device
6 August 2008
Dormio Tech, a division of CHAD Therapeutics, Inc. (AMEX:CTU), has
received 510(K) clearance from the FDA for its FloChannel Diagnostic
System, Dormio's first product for the large and rapidly growing sleep
"With its patented features and unique capabilities, we believe
FloCHANNEL is a significant advance in the diagnosis of obstructive
sleep apnea and other sleep disorders, and may become an invaluable tool
in attended sleep laboratories," said President and CEO Earl Yager.
There are approximately 2,800 attended sleep labs in the United States.
Dormio Tech says its FloChannel is the only diagnostic device that
independently monitors left and right nasal airflow. This allows the
system to detect and measure nasal cycling (the periodic alternation in
nasal airflow resistance between the two nasal cavities), as well as
oral airflow and snoring, and provides constant baseline airflow
volumetric sleep scoring. The patented device connects easily to
standard sleep lab systems.
CHAD currently expects to begin shipping the device and associated
disposables by September this year.