The diagnostics game has changed dramatically over the past 15 years. Old-school companies placed their bets on high-volume, low-margin tests, but today's molecular diagnostics players are all about value proposition. The market is hungry for simple tests that impact patient outcomes while also taking costs out of the system.
Edwards Lifesciences Corp. appears to be milking as many indications as possible from its transcatheter heart valve (THV) platform. The FDA just approved the company's Sapien XT valve for pulmonic valve replacement procedures in both adults and children with either a narrowed pulmonary valve or pulmonary regurgitation caused by congenital heart disease.
Nexstim Plc faces an uncertain future with its Navigated Brain Therapy (NBT) for stroke rehabilitation after a phase III study of the device failed to meet its primary endpoint.