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Royal Philips said Tuesday it had reached an enrollment goal of 2,500 patients in its Sleep Apnea cardioVascular Endpoints (SAVE) trial. Preliminary results are expected in 2016. Read More
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