Devices

Uniform AI/ML Marketing Guidelines Needed: Study

New York University researchers say there can be discrepancies between the marketing and 510(k) clearance of artificial intelligence (AI)- or machine learning (ML)-enabled devices, with some devices marketed as having such capabilities not approved by FDA for AI or ML. Writing in an online JAMA Network article, the researchers say that in a review of 119 FDA 510(k) clearance summaries for devices approved between 11/2021 and 3/2022, they found that 12.6% were considered discrepant, 6.7% were considered contentious, and 80.6% were consistent between marketing and clearance summaries.

“The aim of this study was not to suggest developers were creating and marketing unsafe or untrustworthy devices,” the researchers conclude, “but to show the need for study on the topic and more uniform guidelines around marketing of software-heavy 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