FDA's
etourderie gaucherie disseminates misinformation
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The FDA, America's
bastion of accuracy in reporting, botches a press release and erroneously
credits an Australian company (MicroMedical)
with receiving "clearance for marketing the first portable,
pocket-sized version of an electrocardiograph (ECG) machine".
The press
release issued on January 8, 2002 states:
"FDA has cleared for marketing the first portable,
pocket-sized version of an electrocardiograph (ECG) machine.
The device, called the Pocketview ECG, is a miniature
version of a standard ECG machine, which is used by doctors to monitor
the heart's health by recording its electrical signals. It performs
the same functions as a standard large ECG machine.
The new product reflects a trend in the medical device industry
toward the miniaturization of large medical devices.
The Pocketview ECG, made by MicroMedical Industries, of Australia,
consists of the pocket-sized ECG device and 12 leads that are placed
on the patient's body by a healthcare professional to record the
ECG information. The recorded data can be viewed on the device or
transmitted using special software via mobile phone or other wireless
networks to a computer for viewing by additional medical personnel.
The Pocketview ECG is capable of storing numerous ECGs and displaying
up to four separate results on the computer screen for simultaneous
comparison.
To develop the product, MicroMedical Industries modified the
software used with standard ECG monitors to adapt it for use with
its miniature version.
FDA cleared the Pocketview ECG based on information supplied
by MicroMedical Industries on design controls used in the manufacture
of the product and on a comparison to standard ECG monitors currently
marketed."
However, The ActiveECG
a Palm powered cardiac monitor from the Active
Corporation of Castine Maine was approved for marketing by the
US FDA in May 2001 and the Therapeutic
Products Directorate of Canada in August 2001. Moreover, Active
has been successfully marketing the ActiveECG since May 16 2001,
and recently received the Top
Powered Up Award from Palm and the Golden
Gadget Award from PDA cortex. (See
our review).
The MicroMedical website is a little less aggresive in their claims
and states: "MicroMedical Achieves FDA Clearance for World
First Pocket Sized ECG Monitor using a Pocket PC". But
an American company; Cardio
Control, Inc, has been marketing Cardio
Perfect CE since August 21, 2001.
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