Devices

FDA $5 Million Grant to Spur Pediatric Device Development

FDA has awarded $5 million to the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), led by Children's National Health System and University of Maryland, College Park. The grant is intended to foster development, production and marketing of the next generation of medical devices designed to meet their needs.

NCC-PDI is tasked to encourage innovative pediatric devices by providing business, regulatory, legal, scientific, engineering and clinical expertise to strengthen pediatric device applications. Under the grant, the consortium will:

Encourage innovation and connect qualified individuals with pediatric device ideas with potential manufacturers
Mentor and manage pediatric device projects though the development process
Connect innovators and physicians to existing federal and non-federal resources
Assess the scientific and medical merit of proposed pediatric device projects
Assist and advise on business development, personnel training, prototype development, post market needs and related activities and
Provide regulatory consultation to device sponsors to support submission of pediatric device applications.

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

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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