Devices

AdvaMed on At-Home Medical Technology Use

AdvaMed says HHS and other federal entities can take steps that are beyond the ability and resources of the medical device industry to increase patient access to at-home use of medical technologies. Commenting on an FDA request for information on the topic, the association says the government can help develop a network of community-based healthcare centers, including those potentially linked with historically Black colleges or university medical programs, rural facilities, and urban medical facilities with concentrations of diverse and underserved populations. The network, it says, could also include community health facilities, clinical societies, community groups, and patient or disease advocacy groups.

AdvaMed encourages FDA to think broadly about ways it could encourage health equity by facilitating availability in less traditional settings that are closer to, and easier to access by, the patient, even if those settings may be “clinical.”

Before addressing questions posed by the agency, the trade group also says it is helpful to look at the unique circumstances surrounding the introduction of in vitro diagnostics that present opportunities for improvement.

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