Redsense blood loss detection device gains EU approval

13 March 2007

Redsense Medical’s device for blood loss detection during haemodialysis has been approved for sale in Europe and granted the CE mark.

The device comprises two parts: a sensor patch and a base unit. Connected to the base unit by a small wire. The sensor patch employs fibre optic technology to continuously monitor the venous needle access point. If the needle dislodges and bleeding begins, an alarm is raised by the base unit worn on the patient’s arm.

The blood loss detection device has proved to be highly effective and user friendly, with no more than an on/off switch.

Dialysis equipment must provide a system to protect the patient from blood loss due to dislodgement of the venous needle. Considerable, or even fatal, blood loss can occur when the venous needle becomes dislodged. Although it is currently permissible that this requirement can be met by venous pressure monitoring, a better solution has long been requested by the medical staff.

After a number of incidents in a Swedish dialysis clinic, cooperation between the clinic's technicians and a company specialising in medical technology led to the creation of Redsense Medical in 2006. The company has offices in Sweden and in the Seattle, USA.

Redsense Medical anticipates approval for the device from the US FDA during spring/summer 2007 and also to start production in this period.

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