FDA clears Medivance's patient cooling device
This article was originally published in Clinica
Executive Summary
Medivance's Arctic Sun 5000, a therapeutic temperature management device, has received 510(k) clearance from the US FDA. The noninvasive patient cooling system monitors core body temperature and can maintain a patient's temperature between 32 and 38.5°C. This could minimise damage to the heart and brain in patients who have suffered a traumatic event, Medivance claims. The device consists of ArcticGel pads, which are placed on the patient's body, a temperature probe, and a touch-screen control module. It is more precise than conventional cooling methods such as ice packs and water blankets, according to the Louisville, Colorado-based company.