Devices

AI Benefits, Challenges in Decision Support Software

The Duke-Margolis Center for Health Policy says artificial intelligence (AI) has been introduced into many areas of medicine, including clinical decision support (CDS) software. It has issued a report examining the benefits and challenges when AI has been incorporated into CDS software, particularly software that supports improved clinical diagnosis, as well as barriers that may be preventing development and adoption of the software.

The paper discusses how AI may improve CDS software and shows current examples across a variety of conditions. It also outlines the legal and regulatory landscape for AI-enabled CDS software, largely affected by FDA’s medical device regulations.

“Due to recent legislation,” it says, “some types of CDS are not considered medical devices (and not subject to FDA regulation), although other types of AI-enabled software remain subject to regulation by the agency. The most impactful regulatory update affecting AI-enabled CDS software is FDA’s proposed precertification program for software that are regulated as medical devices.”

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