Drugs

Hyperfine Research 510(k) Cleared for Brain Imaging

FDA has cleared a Hyperfine Research 510(k) for its deep-learning image analysis software to measure brain structure and pathology in images acquired by the Swoop Portable MR Imaging System. The analysis software relies on tools featuring automatic measurement of ventricular volume, brain extraction, brain alignment, and midline shift — a clinical measure of brain injury, the company says. It uses advanced artificial intelligence features to “analyze and return annotated and segmented brain images, providing clinicians of all levels of expertise with quantitative markers for decision support and immediate feedback for diagnostic insight,” it says.

Hyperfine’s new device is designed to be wheeled directly to a patient’s bedside, plugged into a standard electrical wall outlet, and controlled by an Apple iPad. Images that display the internal structure of the head are captured by Swoop at the patient’s bedside to facilitate critical decision-making capabilities across a variety of clinical settings, the company 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