Devices

2 FDA Recommendations in Patient Safety Report

A report submitted by the President’s Council of Advisors on Science and Technology to President Joseph Biden on “A Transformational Effort on Patient Safety” contains two recommendations for FDA action. The report says patient safety is an urgent national public health issue, with recent data showing about one in four Medicare patients experience adverse events during hospitalizations. More than 40% of the events are preventable, it says.

The report suggests that FDA consider defining a risk rating system for medical devices that provides specific guidance for devices according to levels of risk and requires routine post-marketing surveillance for evaluation of the devices, especially when new technology is being deployed clinically.

The second recommendation is that several HHS agencies collaborate with FDA to consider establishing a program of “AI for Patient Safety,” aimed at pooling and sharing best practices and providing information on the integration of technologies for sensing and monitoring, data analytics, and AI systems within current hospital workflows.

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