The U.S. Food and Drug Administration has given 510(k) clearance to Cardium Therapeutics’ operating unit InnerCool Therapies, Inc. for the commercialization of its RapidBlue(TM) System, a system to regulate body temperature. The closed loop catheter-based system of the device modulates body temperature by circulating saline within the catheter’s interior. Underwriters Laboratories found that the system met all the medical electrical safety standards including UL 471 Standard for commercial refrigerators, the first global certification for an endovascular thermal regulating device.