Devices

Workshop on Medical Extended Reality Devices

FDA has announced a 3/5 public workshop entitled “Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine.” The workshop will discuss evaluation techniques for hardware, standards development, and assessment challenges for applications involving “extended reality (XR)” in medicine. Experts says that XR technologies, which include virtual reality and augmented reality, are already impacting key patient care areas in dozens of innovative applications — from medical and skill-based training to the assisted delivery of high-precision robotic surgery.

The workshop’s goal is to “identify critical gaps that may impede medical XR device development, innovation, and to advance the evaluation of medical XR devices and applications, thus accelerating the development of safe and effective medical XR devices benefiting patients and healthcare,” FDA says. “ The overarching vision of the workshop is to help advance the development of evaluation techniques for medical XR devices and applications to ultimately accelerate the development of safe and effective medical uses of XR, providing benefits to patients.”

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