Devices

Takeaways from FDA AI/ML Transparency Workshop

Two Morrison Foerster attorneys say an FDA 10/14 virtual public workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML (artificial intelligence/machine learning) technology in the medical device space, with an emphasis on information-sharing methods for patients, caregivers, and providers. The attorneys list these five workshop takeaways:

cultivating user awareness for both patients and healthcare providers will be a key area of focus for AI/ML-enabled device manufacturers and regulators going forward;
transparency and effective communication of AI/ML medical device labeling will be important to consider for all user types;
bias and systemic discrimination remain persistent issues in the AI/ML space;
inequality, from both a patient and a manufacturer perspective, was a key workshop conversation topic; and
transparency surrounding tracking and reporting of device errors or malfunctions will be an important discussion topic as AI/ML-enabled devices are made available.

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