FDA Clears Redsense Safety Device for Home Hemodialysis

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HALMSTAD, Sweden—The U.S. Food and Drug Administration (FDA) has cleared the Redsense safety device  for home/self-use and is consequently available to all patients with home hemodialysis in the United States, according to Redsense Medical.

Redsense safety device is designed to detect venous needle dislodgement during hemodialysis.

The current 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, Redsense pointed out that incidents have been reported whereby significant blood loss occurred before the venous pressure alarm sounded, resulting in serious, even fatal consequences.

The Redsense device has 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. The Redsense blood detection device 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.

“This is where Redsense really can make a difference,” said Redsense CEO Patrik Byhmer.” It's very satisfying being able to increase the level of safety among the users of home hemodialysis.

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