Regulatory
Approvals
AMDG has already achieved the European CE mark for the VariaCardio®
TF5 and is well advanced in preparing the necessary information
to obtain FDA 510(k) approval to market the TF5 in the USA.
Heart Rate Variability ("HRV")
Clinical Advocacy
Numerous scientific studies throughout the world have shown
that the use of Heart Rate Variability monitors can detect
the onset of cardiovascular disturbance prior to any signs
of damage to the heart.
The VariaCardio®TF5 is the first instrument in the world
to offer doctors an easy and fast telemetric analysis of Heart
Rate Variability. The high sampling frequency and advanced
statistical analysis ensures accurate results in only 15 minutes.
Existing Medical Partners and
Distributors
In the UK AMDG is working in close collaboration with both
Dr Jim Nolan's hospital (Stoke City General) and Dr. Mike
Chester (at the Cardiac-Thoracic Centre, Liverpool and the
National Refractory Angina Centre, Liverpool). A 'two centre'
study to further refine and validate the VariaCardio®
TF5 for cardiac risk stratification.
AMDG has appointed Beaver Medical as a distributor in the
UK to represent the VariaCardio® TF5 in the NHS and Private
Hospital sector and will shortly sign a distribution agreement
with EU-Medical to represent the VariaCardio® TF5 in Germany
Following several presentations in the USA, AMDG has received
many extremely favourable responses regarding the possibilities
of setting up regionwide distribution agencies in both Southern
California, Florida, New York, Arizona and Minneapolis in
the USA .
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