3.02.2007

FDA Not Impressed

From The NY Times:

Medicine’s march toward remote monitoring of patients hit at least a temporary roadblock yesterday.

An implanted wireless device intended to continuously monitor patients with weak hearts — and then provide the data to doctors via the Internet — did not keep enough of them out of the hospital to prove its effectiveness, according to a panel of experts assembled by the Food and Drug Administration.

The device’s manufacturer, Medtronic, has been developing wireless data-gathering technology for implanted therapeutic devices like defibrillators and insulin pumps. It aimed to make the product reviewed yesterday, a device the size of a pocket watch and known as the Chronicle implantable hemodynamic monitor, the first major implant approved solely for diagnostic monitoring.

More.

Seemed like it should help...




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