Devices

Body Vision’s LungVision 2.0 System Cleared

FDA has cleared a Body Vision Medical 510(k) for the LungVision 2.0 System. The new device features “real-time tool-in-lesion confirmation combined with seamless integration of LungVision Tool, a disposable lung navigation catheter,” according to the company. The LungVision Tool, which is guided by the LungVision 2.0 System, is used through standard bronchoscopes to allow access of any endotherapy accessories to small pulmonary nodules, it says.

The device uses machine learning and for accurate real-time navigation, and it allows physicians to plan, visualize, and track endobronchial tools inside radiolucent lesions in real time, Body Vision says. It also reveals fluoroscopically “blind” lesions during biopsy sampling through any conventional C-Arm, which is widely available in a standard bronchoscopy suite, it says.

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