Results 11 to 20 of about 831,296 (284)
Postmarketing Trials and Pediatric Device Approvals [PDF]
Pediatrics, 2014 BACKGROUND: Medical devices can be useful in a variety of diseases, but few devices have been specifically approved for use in children. The 2007 Pediatric Medical Device Safety and Improvement Act was passed to stimulate pediatric device development.
Hwang, Thomas +2 more
openaire +5 more sources
Regulatory Approval With Real-World Data From Regulatory Science Perspective in Japan
Frontiers in Medicine, 2022 Recently, there has been a growing trend in clinical development to utilize real-world data (RWD) to improve the efficiency of drug/medical device development.
Hideki Maeda +2 more
doaj +1 more source
JACC: Basic to Translational Science, 2016 The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes as quickly as possible.
Gail A. Van Norman, MD
doaj +1 more source
Current Directions in Biomedical Engineering, 2022 The development of novel and innovative biomaterials and biomedical devices like medical implants is a sophisticated task that requires expertise ranging from physicians over engineers and natural scientists to regulatory officers for clinical ...
Doll Katharina +3 more
doaj +1 more source
Revista Médica Clínica Las Condes, 2023 Resumen: El dispositivo inflable OdonAssist™ para parto vaginal asistido es un dispositivo de investigación que se sometió a pruebas clínicas previas a la comercialización.
Mario Merialdi
doaj +1 more source
REGULATORY APPROVAL OF NEW MEDICAL DEVICES: A CROSS SECTIONAL STUDY [PDF]
, 2016 Objective To investigate the regulatory approval of new medical devices. Design Cross sectional study of new medical devices reported in the biomedical literature.
Darzi, A +6 more
core +2 more sources
Revista Médica Clínica Las Condes, 2023 The OdonAssist™ inflatable device for assisted vaginal birth is an investigational device which underwent premarket clinical testing. The clinical evidence generation plan includes preclinical and clinical studies to support development, regulatory ...
Mario Merialdi
doaj +1 more source
The future of glaucoma surgery
Journal of Ophthalmic & Vision Research, 2015 Glaucoma surgery is ripe for innovation. In the last few years, there has been a substantial increase in the number of devices approaching commercialization.
Arsham Sheybani
doaj +1 more source
Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group [PDF]
, 2017 The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual.
Bergenstal, Richard M. +5 more
core +4 more sources
Ultrasound-guided trans-rectal high-intensity focused ultrasound (HIFU) for advanced cervical cancer ablation is feasible: a case report. [PDF]
, 2015 High-intensity focused ultrasound (HIFU) is an ablative treatment undergoing assessment for the treatment of benign and malignant disease. We describe the first reported intracavitary HIFU ablation for recurrent, unresectable and symptomatic cervical ...
Abel, M +9 more
core +1 more source