Surefire Medical Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its line of Surefire angiographic catheters. Surefire Medical will launch these products in the United States later this year.

Boston Scientific Corporation has begun the United States and European launch of its Victory guidewire, designed to facilitate crossing of resistant lesions and the placement and exchange of balloon catheters or other interventional devices within the peripheral vasculature. The company expects to launch the product in other international markets later this year and in 2013, subject to regulatory approvals.

The U.S. Food and Drug Administration (FDA) has granted Boston Scientific Corp. regulatory approval for its S-ICD System, the world's first commercially available subcutaneous implantable cardioverter defibrillator (S-ICD). It sits entirely just below the skin without the need for implantable lead to be placed inside the heart.

The U.S. Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA)-waived status to the Roche CoaguChek XS Plus system. The point-of-care anticoagulation monitor offers connectivity and data management tools to help healthcare professionals manage PT/INR (blood clotting time) testing. The waiver means that the monitoring technology may now be used in a broader range of clinical settings, such as labs that do not meet the requirements to perform moderate- or high-complexity testing as defined by the CLIA of 1988.