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The FDA’s Center for Devices and Radiological Health is working on ways to permit sponsors to use more adult clinical trial data in proving the safety and effectiveness of pediatric medical devices. Read More
The IRB at a major Chicago hospital has been handed an FDA warning letter for a slew of violations in a device clinical trial, many of which were first observed at the site over a decade ago. Read More
New device registries should only be launched if they are the least burdensome way to meet scientific objectives, AdvaMed says in a revised document on registry principles released Tuesday. Read More
The promising new hypertension treatment known as renal denervation is safe in the short to medium term, but more safety information is needed before conclusions can be drawn about its long-term benefits versus standard care in treating treatment-resistant hypertension. Read More
India’s Ministry of Health and Family Welfare said it will create a Medical Technology Assessment Board to evaluate existing and new technologies and accelerate production by local devicemakers. Read More
Sponsors of clinical trials in India must inform enrollees during videotaped informed consent sessions about potential payments resulting from adverse events, a draft guideline says. Read More
The FDA and American Glaucoma Society will hold a workshop to discuss clinical trial design and safety parameters for minimally invasive glaucoma surgery. Read More
An institutional review board at one of Chicago’s major hospitals was handed an FDA warning letter for a slew of violations — many cited previously — in a medical device clinical trial. Read More