Devices

RealView Imaging Holographic Device Cleared

FDA has cleared a RealView Imaging 510(k) for its Holoscope-i holographic system for creating spatially accurate, three-dimensional interactive medical holograms based on data received from standard CT scans and 3D ultrasound systems. The device features an over-the-head system configuration suspended above the physician, without the need for any head-mounted device, special eyewear or interaction tools, the company says. “Based on the company’s proprietary Digital Light Shaping technology, the Holoscope-i is the only commercial product which employs true interference-based volumetric holography (a Nobel Prize winning technology) to create holograms with high spatial resolution in all three dimensions,” it says. The device also allows natural 3D/4D visualization and prolonged use of the system without causing fatigue, nausea or headache, which are the major problems with all currently available 3D stereoscopic visualization solutions, (augmented reality headsets, virtual reality headsets and stereoscopic screens), RealView 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