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Redsense gets US nod for needle dislodgement alarm:

This article was originally published in Clinica

Executive Summary

Swedish firm Redsense Medical has received 510(k) clearance from the US FDA for its alarm for venous needle dislodgement. The device, for use in haemodialysis patients, can detect as little as 1mm of blood that is released after dislodgement. The product, called Redsense, consists of two parts: a sensor patch and an alarm unit. In the event of bleeding, inner layers of the patch smear blood over the optical sensor, which triggers the alarm. Over 200 million dialysis treatments are performed every year, a number set to increase with the world's ageing population, claimed the Halmstad company. Serious incidents due to needle dislodgment during haemodialysis are estimated to be in the thousands, said Redsense.

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