Devices

GE’s Optison OK’d for Pediatric Heart Imaging

FDA has approved GE HealthCare’s ultrasound imaging agent Optison 9 (perflutren protein-type a microspheres injectable suspension) for use in pediatric patients. The drug, which contains gas-filled microbubbles that enhance the visibility of heart chambers and walls during ultrasound imaging, was previously approved for adult use in 1997.

The agent improves the accuracy of cardiac assessments by clearly defining endocardial borders and enhancing left ventricular function measurements — critical elements in diagnosing heart conditions, the company says. Unlike other ultrasound agents, Optison does not contain polyethylene glycol, a compound that can cause allergic reactions in some patients, it adds.

Expanded approval was based on findings from a multicenter Phase 4 study, which showed that Optison significantly improved image quality in children with suboptimal echocardiograms, GE says. The agent also reduced the number of unclear images and improved visualization of heart wall segments.

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