Devices

New AI Transparency Minimums Needed: Column

Two artificial intelligence (AI) experts writing in a Stat News opinion column say there are four areas in which bias can enter an algorithm used in medicine that should be addressed by FDA. Gesund CEO Enes Hosgor and radiologist Oguz Akin say the four areas that can skew the performance of any clinical algorithm are patient cohorts, medical devices, clinical sites, and the algorithms themselves. They say the four potential biases are not being systematically accounted for in submissions to FDA.

“We propose new mandatory transparency minimums that must be included for FDA to review an algorithm,” the two write. “These span performance across dataset sites and patient populations; performance metrics across patients cohorts …, and the different devices the AI will run in. This granularity should be provided both for the training and the validation datasets.”

The article says that proposing a baseline performance standard is a profoundly complex undertaking. It says the intended use of each algorithm drives the necessary performance threshold level, with higher-risk situations needing a higher standard for performance, and is therefore hard to generalize. “While the industry works toward a better understanding of performance standards,” Hosgor and Akin say, “developers of AI must be transparent about the assumptions being made in the data.”

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