Devices

FDA Launches ‘Home as a Healthcare Hub’

CDRH says it is launching a Home as a Healthcare Hub initiative “to help reimagine the home environment as an integral part of the healthcare system, with the goal of advancing health equity for all people in the U.S.” An announcement says the Center has contracted with an architectural firm that intentionally designs innovative buildings with health and equity in mind to consider the needs of variable models of a home and tailor solutions with opportunities to adapt and evolve in complexity and scale.

“The hub will be designed as an augmented reality/virtual reality-enabled home prototype and is expected to be completed later this year,” says CDRH director Jeffrey Shuren.

He says the partnership working on the project includes collaboration with patient groups, healthcare providers, and the medical device industry to build the home as a Healthcare Hub. “The prototype will serve as an idea lab, not only to connect with populations most affected by health inequity,” he says, “but also for medical device developers, policymakers, and providers to begin developing home-based solutions that advance health equity.”

FDA is using diabetes as an example health condition for the prototype based on the impacts over the lifecycle of someone living with the condition, Shuren says.

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