- Written by Rob Littlefield, MSc - GlobalData's Analyst covering Cardiovascular Devices.

On September 28, 2012, the US Food and Drug Administration granted the Boston Scientific Corporation (BSX) regulatory approval for its first-in-class subcutaneous implantable defibrillator (S-ICD) system. This S-ICD system establishes the first new category of cardiac rhythm management devices since the introduction of cardiac resynchronization therapy. The device is manufactured by Cameron Health, Inc. (San Clemente, CA), which was acquired by BSX (Natick, MA) this June for $150m upfront, with additional payments of $150m for device approval and $1.05 billion for sales targets as they’re reached.