Devices

Duke Center Sets Medical Device Priorities

Duke University’s National Evaluation System for health Technology (NEST) planning board has outlined key priorities for its new coordinating center as it works to implement a national system for medical device evaluation. The 25-member board includes patients, clinicians, the medical device industry, payers, and regulatory experts, as well as five representatives from federal agencies. A NEST statement says that the coordinating center is charged with implementing a national network of partners to improve evidence medical device safety and effectiveness to help improve patient care though better use of real-world electronic health data and developing new tools for more efficient device analyses.

The planning board recommends that the coordinating center drive the development of the system through strategically chosen and innovative demonstration projects that build cooperative agreements and promote methodologies that will help NEST scale quickly. The board also emphasized the importance of patient input and addressing long-term technical challenges such as the importance of unique device identifiers.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome