Devices

Cardiologist to Lead Digital Health Panel

American College of Cardiology chief innovation officer Ami Bhatt has been selected to serve a four-year term as chair of FDA’s recently created Digital Health Advisory Committee. The committee was established 10/2023 to provide advice on complex scientific and technical issues related to digital health technologies (DHTs), according to the agency. This also may include advice on the regulation of DHTs and their use, including use of DHTs in clinical trials or postmarket studies. Topics relating to DHTs, such as artificial intelligence (AI)/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may also be considered by the committee, it says.

The committee is scheduled to convene its first meeting in November on generative AI technologies, including its potential impact on device safety and effectiveness.

Bhatt is also a cardiologist with Massachusetts General Hospital, and an associate professor at Harvard Medical School. Her term as committee chair will run until 7/31/2028.

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