FDA News Briefs for Monday, January 29, 2018January 29, 2018
These Food and Drug Administration (FDA) developments came in late last week:
FDA Approves Lutathera for Gastroenteropancreatic Neuroendocrine Tumors
The FDA has approved Lutathera (lutetium lu 177 dotatate; Advanced Accelerator Applications USA Inc.), a radiolabeled somatostatin analog indicated for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. More Information.
FDA Grants Clearance for Cyberdyne HAL System
The FDA has granted 510(k) clearance for Cyberdyne’s Hybrid Assistive Limb (HAL), a robotic exoskeleton intended for individuals with spinal cord injury who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL gait training is intended to be used in conjunction with regular physiotherapy; it is intended for use inside medical facilities under trained medical supervision. More Information.