News | November 01, 2007

Redsense Medical Receives FDA Approval for Blood Loss Detection Device

November 1, 2007 - Redsense Medical’s blood loss detection device for monitoring venous needle dislodgement has been granted FDA approval, and is now available for sale in the United States.

The Swedish company says the device has already been granted CE approval. With the FDA’s approval, the maker says Redsense is the first clinically tested, reliable blood loss monitoring system available in the U.S.

About 1.5 million patients worldwide receive more than 200 million dialysis treatments every year. The size of the market is forecast to increase due to an aging population and the rise of diseases such as diabetes type II. Medical professionals have long been aware of the risk of venous needle dislodgement during dialysis treatment.

Until now, the typical method of needle dislodgement detection for this common form of renal therapy has been venous pressure monitoring, a built-in function of all dialysis machines. However, incidents have been reported whereby significant blood loss occurred before the venous pressure alarm sounded, resulting in serious, even fatal consequences.

Redsense consists of two parts - a sensor patch and an alarm unit. An infrared signal is transmitted from the alarm unit to the sensor patch using fiber optic cable. In the event of bleeding, inner layers of the patch smear blood over the optical sensor, which triggers the alarm. Redsense doesn't react to perspiration or water, so moisture alone will not cause an alarm. And because the signal to the sensor is continuous, the alarm reacts instantly to the first milliliter of blood. Nurses and doctors are free to focus on the tangible problems of hemodialysis. And the patient can benefit from the care of professionals who feel in control of their situation.

For more information: www.redsensemedical.com

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