CHICAGO — After building momentum for two years, Samsung (Seoul, South Korea) fully entered the medical imaging market at the big show, the annual meeting of the Radiological Society of North America (RSNA; Oak Brook, Illinois).

It's been a long road for HeartWare International (Framingham, Massachusetts), but the company's patience and perseverance has finally paid off. The FDA has approved the company's premarket approval application (PMA) for its HeartWare ventricular assist system (VAS) as a bridge-to-transplantation (BTT) therapy for patients with end-stage heart failure. HeartWare submitted the PMA nearly two years ago (Medical Device Daily, Dec. 29, 2010).