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FDA's etourderie gaucherie disseminates misinformation

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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