Devices

FDA Clears Perimeter Optical Coherence Tomography System

FDA has cleared a Perimeter Medical Imaging 510(k) for its OTIS 1.0 Optical Coherence Tomography System. The company says the device provides “high-resolution, real-time imaging of the periphery of excised tissue, enabling clinicians to visualize sub-surface structures up to 2 mm below the surface. These sub-surface structures would otherwise not be evident until days – and often weeks – later when conventional histology slides are available for review.”OTIS is indicated for use as an imaging tool in evaluating excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, Perimeter says. “Previously-cleared devices required the clinician-user to move his/her hand to collect ‘point-by-point’ images, increasing operator workload and generating images from only a small number of points on the specimen,” it says. “The OTIS leverages Perimeter’s proprietary Wide-Field Optical Coherence Tomography Imaging technique to overcome this limitation, leading to rapid, intuitive imaging of the entire specimen.”

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