FDA nod to InnerCool’s Rapid Blue System
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.

TyRx, Inc.
ed FDA approval for two implantable defibrillators, CONFIENT and LIVIAN, and an upgraded LATITUDE Patient Management System. The CONFIENT ICD (implantable cardioverter defibrillator) helps protect patients at risk of sudden cardiac death. The LIVIAN CRT-D (cardiac resynchronization therapy defibrillator) provides cardiac resynchronization and defibrillation therapies in a single device. The upgraded Latitude Patient Management System enables physicians to remotely monitor patients.
The delay in Trasylol’s withdrawal from the U.S. market may have resulted in the death of 22,000 patients, according to a medical researcher.
Patients are at a higher risk of a cardiovascular incident and maybe even death during the first three months after they stop taking