Devices

Concerns About AI in Radiological Imaging

The American College of Radiology and the Radiological Society of North America say it is unlikely that FDA could provide reasonable assurance of the safety and effectiveness of autonomous artificial intelligence (AI) in radiology patient care without more rigorous testing, surveillance, and other oversight mechanisms throughout the total product life cycle. The two professional associations commented on an FDA 2/25-2/26 public workshop on the evolving role of AI in radiological imaging.

“Before developing pathways for the authorization of autonomous functioning AI in radiological imaging, FDA should first wait until current AI algorithms have a broader penetrance in the marketplace so that their efficacy and safety in a supervised manner can be documented, which could then inform decision making regarding the premarket approval and post-market surveillance process requisite for autonomously functioning AI,” the letter says. “If the goal of autonomous AI is to remove the physician from the image interpretation, then the public must be assured that the algorithm will be as safe and effective as the physicians it replaces, which includes the ability to incorporate available context and identify secondary findings that would typically be identified during physician interpretation.”

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