FDA Announces Patient Registry For RWE On New Pediatric Spine Device

FDA on Friday (Aug. 16) announced the first-ever approval of a spinal tether device designed to treat a common form of scoliosis in children and adolescents. The device maker also will develop a patient registry to assess the long-term performance of the device and track real-world evidence of its safety and effectiveness. The development of the registry complements a long-standing effort by FDA to encourage the use of patient registries and other data, including electronic health records and claims data,...