Devices

FDA OKs Hologic’s 3DQuorum Imaging Technology

FDA has approved a Hologic PMA for its 3DQuorum Imaging Technology for use with the company’s Clarity HD high resolution imaging technology to reduce tomosynthesis image volume for radiologists. The 3DQuorum technology uses Hologic’s Genius Artificial Intelligence-powered analytics to reconstruct high-resolution 3D data to produce 6 mm “SmartSlices.” The company says that these analytics “identify clinically relevant regions of interest and preserve important features during reconstruction of the SmartSlices. SmartSlices expedite read time by reducing the number of images for radiologists to review, without compromising image quality, sensitivity or accuracy. With 3DQuorum technology, the number of 3D images to review is reduced by two-thirds, saving an average of one hour per eight hours of daily image interpretation time.”

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