June 22, 2012 — The the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee voted in May against recommending approval of expanding the indication for rivaroxaban (Xarelto) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).


 

June 21, 2012 — A class action suit has been filed against St. Jude Medical Inc. on behalf of purchasers of the company's defibrillator leads. The Riata and Riata ST electrical wire leads were observed to wear through the silicone casing meant to contain them, going on to protrude into the body.

 

June 21, 2012 — Zoll Medical Corporation, a manufacturer of medical devices and related software solutions, announced that Oxford County EMS in Ontario, Canada, is the first emergency service in North America to use a new system that allows rescuers to defibrillate a heart without stopping chest compressions for defibrillation.

June 21, 2012 — TriReme Medical Inc. (TMI) announced today that it has received U.S. Food and Drug Administration (FDA) clearance for an expanded matrix of sizes for its Chocolate percutaneous transluminal angioplasty (PTA) balloon catheter.

June 21, 2012 — Surefire Medical Inc. announced that it has received 510(k) U.S. Food and Drug Administration (FDA) clearance to market the Surefire high-flow microcatheter, the next generation of the company's novel infusion technology. The Surefire system is designed to deliver therapy with higher infusion efficiency than conventional microcatheters.

 
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