Devices

Panelists Review CDRH Digital Health Goals

During an 11/12 online listening session for the CDRH Digital Health Center of Excellence (DHCoE), a panel of industry experts discussed whether FDA has developed the correct goals for the DHCoE and how best to collaborate on the Center’s work. DHCoE director Bakul Patel said FDA considers digital health to be a convergance of connectivity data and computing power for healthcare and its related uses across the lifecycle of the life of an individual or patient.

“Digital health has the potential to move healthcare from our traditional settings to the patients themselves,” he said. While FDA has been playing a role in the digital health space, Patel said, the agency believes there are areas of technology for which the agency and industry must be on the same page for expectations and standards.

Patel also noted that in the current Covid-19 pandemic environment, the clinical studies that are happening for medical products are extremely powerful when they use digital technology.

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