Everist Genomics, a personalized medicine
company developing and commercializing diagnostics and prognostics, announced
plans to commercialize its CardioDefender diagnostic system.
CardioDefender is the first FDA-approved
and CE mark-registered smartphone ECG system to provide physicians and patients
with hospital-quality heart rhythm monitoring outside of the hospital setting.
The system incorporates several unique
capabilities enabling physicians to diagnose and treat potentially life
threatening arrhythmias that might otherwise be missed.
CardioDefender delivers mobile, real-time,
beat-by-beat, and quantitative heart monitoring and automated reporting by
combining patented analytical smartphone software with a Bluetooth device and
electrodes. The electrodes, which are attached to the patient’s skin,
transmit heart rhythm data to the Bluetooth device, which then transmits the
data to the smartphone.
The smartphone software analyzes the heart
rhythm data, and the data is sent to a cardiac monitoring center which keeps an
encrypted record of the data that can be reviewed by physicians.
Physicians are also able to receive arrhythmia alerts via their smartphone,
tablet, laptop or desktop computer. In the event of a significant
arrhythmia, the CardioDefender system will automatically transmit an alert to
the patient’s physician while the event is occurring.
“Until now, heart rhythm monitoring
for arrhythmia events has been limited by technologies that lack the level of
sophistication needed to provide practical and useful monitoring for a
mobile population,” said Prasad Sunkara, chief executive officer of
Following FDA approval and European CE Mark
registration last year, CardioDefender has already been deployed at more than
150 medical facilities in the United States for post-approval commercial evaluation.
Between January and October of this year, the number of patient days of heart
rhythm monitoring performed with CardioDefender grew from fewer than 5,000 to
more than 18,000 patient days per month.
The commercial evaluation of CardioDefender
has been a big success as the system has already been widely adopted and used
to provide heart rhythm monitoring for thousands of patients.
This further demonstrates the growing
consensus among the medical community that it is time for a better approach to
managing heart arrhythmia. By empowering physicians with the first mobile
system to deliver real-time, beat-by-beat, quantitative monitoring and
automated reporting, we are bringing the better approach to fruition.
This diagnostic system represents a significant
advance in Everist Genomics’ franchise of cardiovascular diagnostic and
prognostic tests and complements the innovative AngioDefender diagnostic device
for assessing endothelial function. The company plans to make the
CardioDefender system commercially available to international markets in
By Telecomlead.com Team