FDA has approved HeartWare’s plan to add more patients to the ENDURANCE trial of its HVAD ventricular assist device as a destination therapy for patients with end-stage heart failure. Results of a pilot trial of GlySure’s continuous glucose monitoring system were presented at a conference in South Africa. More research.

HeartWare sold 134 HVAD ventricular assist systems in the U.S. following FDA approval in November and continues to rapidly add more centers to its customer base.

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.